CONTOUR® NEXT 7314Recalls & reported problems

Summary

The FDA's MAUDE database contains 227 adverse event reports that list this exact device (DI 10301937314015), received between Nov 21, 2017 and Apr 10, 2026 — classified as 1 injury, 226 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (220 reports).

1 other recall cover devices cleared under the same FDA submission (K121190, K151742, K160430, K160682, K162336, K191286, K193407, K210687, K223293, K241787); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 227 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT GEN METER. DURING TROUBLESHOOTING, A CONTROL TEST WAS RUN AND A READING OF 196 MG/DL WAS OBTAINED. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER¿S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24845330 ↗
• MalfunctionFeb 2, 2026Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER CONTACTED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT GEN METER, AS HE PERFORMED A CONTROL TEST AND THE READING WAS AUTOMATICALLY MARKED AS A BLOOD RESULT IN THE METER'S MEMORY. SINCE THE CUSTOMER USED INCORRECT TESTING TECHNIQUE, DURING TROUBLESHOOTING, ANOTHER CONTROL TEST WAS PERFORMED USING THE CORRECT TESTING TECHNIQUE AND A READING OF 130 MG/DL WAS OBTAINED. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL RESULT, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236185 ↗
• MalfunctionSep 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE PERFORMED A CONTROL TEST WITH THE CONTOUR® NEXT GEN METER AND OBTAINED A READING OF 176 MG/DL AT 9:38 A.M. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038438 ↗
• MalfunctionSep 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT GEN METER. DURING TROUBLESHOOTING, A CONTROL TEST WAS RUN AND A READING OF 186 MG/DL AT 4:34 P.M. WAS OBTAINED. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER REFUSED TO RETURN THE SUSPECTED DEVICE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23038435 ↗
• MalfunctionSep 10, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE PERFORMED CONTROL TESTS WITH THE CONTOUR® NEXT ONE METER AND OBTAINED READINGS OF 224 MG/DL AT 4:45 P.M. AND 204 MG/DL AT 4:46 P.M. THE METER DID NOT AUTOMATICALLY MARK THE READINGS AS CONTROL TESTS, AND SO THE READINGS WILL BE DISPLAYED AS BLOOD RESULTS WHEN ACCESSING THE METER'S MEMORY. DURING TROUBLESHOOTING, ADDITIONAL THREE CONTROL TESTS WERE PERFORMED AND READINGS OF 124 MG/DL AT 5:18 P.M., 124 MG/DL AT 5:22 P.M. AND 127 MG/DL AT 5:24 P.M. WERE OBTAINED, WHICH WERE PROPERLY MARKED AS CONTROL TESTS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23016613 ↗
• MalfunctionSep 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE PERFORMED A CONTROL TEST WITH THE CONTOUR® NEXT GEN METER AND OBTAINED A READING OF 205 MG/DL AT 12:56 P.M. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER REFUSED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993008 ↗
• MalfunctionSep 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE PERFORMED CONTROL TESTS WITH THE CONTOUR® NEXT ONE METER AND OBTAINED READINGS OF 182 MG/DL AT 11:07 A.M., 142 MG/DL AT 11:11 A.M. AND 206 MG/DL AT 11:19 A.M. THE METER DID NOT AUTOMATICALLY MARK THE READINGS OF 182 MG/DL AND 206 MG/DL AS CONTROL TESTS, AND SO THE READINGS WILL BE DISPLAYED AS BLOOD RESULTS WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993000 ↗
• MalfunctionSep 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT GEN METER. DURING TROUBLESHOOTING, TWO CONTROL TESTS WERE RUN AND READINGS OF 158 MG/DL AND 338 MG/DL WERE OBTAINED. THE METER DID NOT AUTOMATICALLY MARK THE READING OF 338 MG/DL AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992999 ↗
• MalfunctionSep 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE PERFORMED A CONTROL TEST WITH THE CONTOUR® NEXT GEN METER AND OBTAINED A READING OF 156 MG/DL AT 7:47 A.M. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22992998 ↗
• MalfunctionJul 22, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE PERFORMED A CONTROL TEST WITH THE CONTOUR® NEXT GEN METER AND OBTAINED A READING OF 276 MG/DL AT 8:40 P.M. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22568643 ↗
• MalfunctionJul 15, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER CONTACTED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT GEN METER. DURING THE TROUBLESHOOTING, TWO CONTROL TESTS WERE RUN AND READINGS OF 139 MG/DL AND 194 MG/DL AT 4:03 P.M. WERE OBTAINED. THE METER DID NOT AUTOMATICALLY MARK THE CONTROL TEST OF 194 MG/DL, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THE READING OF 139 MG/DL WAS PROPERLY MARKED AS A CONTROL RESULT. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22509351 ↗
• MalfunctionJun 9, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THE CUSTOMER ALLEGED THAT THERE WERE MISSING LOT NUMBER AND EXPIRATION DATE ON THE LABEL OF THE CONTOUR® NEXT CONTROL SOLUTION VIAL. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT TEST STRIPS AND CONTROL SOLUTION WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22168992 ↗
• MalfunctionJun 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER CONTACTED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH THE CONTOUR® NEXT GEN METER. DURING THE TROUBLESHOOTING, THREE CONTROL TESTS WERE RUN AND READINGS OF 140 MG/DL AT 2:05 P.M., 135 MG/DL AT 2:09 P.M. AND 227 MG/DL AT 2:12 P.M. WERE OBTAINED. THE METER DID NOT AUTOMATICALLY THE CONTROL TEST OF 227 MG/DL, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THE READINGS OF 140 MG/DL AND 135 MG/DL WERE PROPERLY MARKED AS CONTROL RESULTS. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22151886 ↗
• MalfunctionMay 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE RAN CONTROL TESTS WITH THE CONTOUR® NEXT GEN METER. NO SPECIFIC READINGS WERE PROVIDED. DURING THE TROUBLESHOOTING, THREE CONTROL TESTS WERE RUN AND READINGS OF 149 MG/DL, 172 MG/DL AND 186 MG/DL WERE OBTAINED. THE METER DID NOT AUTOMATICALLY MARK ANY OF THE CONTROL TESTS, AND SO THE READINGS WILL BE DISPLAYED AS BLOOD RESULTS WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986168 ↗
• MalfunctionApr 25, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN ADVOCATE CALLED ON BEHALF OF HER HUSBAND TO REPORT THAT THEY RAN A CONTROL TEST WITH THE CONTOUR® NEXT GEN METER AND OBTAINED A READING OF 156 MG/DL AT 9:00 A.M. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909251 ↗
• MalfunctionNov 2, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE RAN CONTROL TESTS WITH THE CONTOUR NEXT ONE METER AND OBTAINED READINGS OF 151 MG/DL AT 9:23 P.M., 219 MG/DL AT 9:25 P.M. AND 227 MG/DL AT 9:32 P.M. THE METER DID NOT AUTOMATICALLY MARK IT AS CONTROL TESTS, AND SO THE READINGS WILL BE DISPLAYED AS BLOOD RESULTS WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20594325 ↗
• MalfunctionOct 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE RAN A CONTROL TEST WITH THE CONTOUR NEXT GEN METER AND OBTAINED A READINGS OF 139 MG/DL AT 8:58 P.M. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513962 ↗
• MalfunctionOct 15, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER CALLED ASCENSIA CUSTOMER SERVICE TO SEEK ASSISTANCE WITH HIS CONTOUR NEXT GEN METER. DURING THE TROUBLESHOOTING, A CONTROL TEST WAS RUN AND A READING OF 227 MG/DL AT 12:31 P.M. WAS OBTAINED. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453652 ↗
• MalfunctionOct 15, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE RAN CONTROL TESTS WITH THE CONTOUR NEXT GEN METER AND OBTAINED READINGS OF 189 MG/DL AT 12:40 P.M., 138 MG/DL 12:51 P.M., 134 MG/DL 12:55 P.M., 153 MG/DL 12:56 P.M., AND 204 MG/DL AT 12:59 P.M. THE METER DID NOT AUTOMATICALLY MARK THEM AS CONTROL TESTS, AND SO THE READINGS WILL BE DISPLAYED AS BLOOD RESULTS WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20453620 ↗
• MalfunctionAug 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER STATED THAT HE RAN A CONTROL TEST WITH THE CONTOUR NEXT GEN METER AND OBTAINED A READING OF 157 MG/DL. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049878 ↗
• MalfunctionAug 23, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER STATED THAT HE RAN A CONTROL TEST WITH THE CONTOUR NEXT GEN METER AND OBTAINED A READING OF 153 MG/DL. THE METER DID NOT AUTOMATICALLY MARK IT AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049877 ↗
• MalfunctionJul 11, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE RAN A CONTROL TEST WITH THE CONTOUR NEXT GEN METER AND OBTAINED A READING OF 88 MG/DL AT 3:25 P.M. THE METER DID NOT AUTOMATICALLY MARK THE READING AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. A REPLACEMENT METER KIT WAS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719317 ↗
• MalfunctionJul 11, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT HE RAN A CONTROL TEST WITH THE CONTOUR NEXT ONE METER AND OBTAINED A READING OF 170 MG/DL AT 1:06 A.M. THE METER DID NOT AUTOMATICALLY MARK THE READING AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS WERE SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19719307 ↗
• MalfunctionJun 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  AN ADVOCATE CALLED ON BEHALF OF THE CUSTOMER TO REPORT THAT THEY PERFORMED A CONTROL TEST WITH THEIR CONTOUR NEXT GEN METER AND OBTAINED A READING OF 202 MG/DL AT 9:26 A.M. THE METER DID NOT AUTOMATICALLY MARK THE READING AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE ADVOCATE WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19574272 ↗
• MalfunctionMay 20, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED THAT SHE RAN CONTROL TESTS WITH THE CONTOUR NEXT ONE METER AND OBTAINED READINGS OF 201 MG/DL AT 7:02 P.M., 125 MG/DL AT 7:04 P.M. AND 117 MG/DL AT 7:05 P.M. THE METER DID NOT AUTOMATICALLY MARK THE READING OF 201 MG/DL AS A CONTROL TEST, AND SO THE READING WILL BE DISPLAYED AS A BLOOD RESULT WHEN ACCESSING THE METER'S MEMORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE CUSTOMER WAS ADVISED TO RETURN THE DEVICE FOR EVALUATION. REPLACEMENT METER KIT AND TEST STRIPS SENT TO THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351270 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121190, K151742, K160430, K160682, K162336, K191286, K193407, K210687, K223293, K241787. One submission often covers many models, so check the product and lot details in each record.

• Z-2211-2023 · May 19, 2023 · Open, Classified
  Contour next GEN Blood Glucose Monitoring System