Prodigy No Coding Blood Glucose Test Strips 075300Recalls & reported problems
Prodigy Diabetes Care, LLC · 1 Box of Prodigy No Coding Blood Glucose Test Strips (50 ct). · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00384840753006), received between Sep 8, 2017 and Oct 6, 2017 — classified as 2 injuries.
The most frequently reported specific device problem is “High Readings” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- High Readings1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- Hyperglycemia1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 6, 2017Incorrect, Inadequate or Imprecise Result or Readings; High Readings; Incorrect, Inadequate or Imprecise Result or Readings; High Readings
THIS IS A SUPPLEMENTAL REPORT TO INITIAL REPORT 3005862821-2017-00097 TO SUBMIT INVESTIGATION RESULTS FROM THE MANUFACTURER FOR THE SUSPECT DEVICES. DEVICES WERE RETURNED FROM PRODIGY DIABETES CARE ON OCT. 12,2017 AND AN INVESTIGATION RESULTS OF THE SUSPECT DEVICES WERE COMPLETED BY OK BIOTECH.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6921446 ↗InjurySep 8, 2017Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2017 AT 6:00 PM AFTER THE END USER RECEIVED HIGHER THAN NORMAL BLOOD GLUCOSE READINGS FROM HIS PRODIGY DIABETES METER. THE END USER PERFORMED A BLOOD GLUCOSE TEST WITH A RESULT OF 336 MG/DL. HE DID NOT EXPERIENCE ANY SIGNIFICANT SYMPTOMS BUT OUT OF CONCERN HE WAS TAKEN TO THE ER AS A PRECAUTION. UPON ARRIVAL TO THE ER HIS BLOOD GLUCOSE WAS 241 MG/DL. THE END USER STATED THAT NO TREATMENT WAS ADMINISTERED TO STABILIZE HIS BLOOD GLUCOSE LEVEL. BLOOD AND URINE TEST WERE PERFORMED AND THE RESULTS WERE NORMAL. AFTER 4 HOURS IN THE ER THE END USER WAS DISCHARGED WITH A BLOOD GLUCOSE READING OF 276 MG/DL AND HE WAS INSTRUCTED TO FOLLOW-UP WITH HIS PCP. NO ADDITIONAL DETAILS WERE PROVIDED IN REGARDS TO THIS MEDICAL EVENT.
Patient problems: Hyperglycemia
MAUDE report 6853299 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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