OneTouch Ping 10143000Recalls & reported problems
Animas Corporation · Rev Kit, OTP, BLU, mg/DL, US · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10840406100808), received between Oct 17, 2016 and Jul 17, 2017 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Date/Time-Related Software Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Date/Time-Related Software Problem1
- Device Issue1
- Inaccurate Delivery1
Patient problems
- Hypoglycemia2
- Confusion/ Disorientation1
- Diaphoresis1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 17, 2017Date/Time-Related Software Problem; Date/Time-Related Software Problem
THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PUMP WAS RETURNED FOR PRODUCT ANALYSIS INVESTIGATION AND THE EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT. THIS REPORT IS MADE BASED ON THE RESULTS OF AN INVESTIGATION COMPLETED ON 06/20/2017.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6718083 ↗InjuryDec 16, 2016Device Issue; Device Issue
THE REPORTER CONTACTED ANIMAS ON (B)(6) 2016 ALLEGING THE PATIENT EXPERIENCED HYPOGLYCEMIA WHILE ON INSULIN PUMP THERAPY WITH BLOOD GLUCOSE MEASURING 40 MG/DL WITH ASSOCIATED SYMPTOMS OF CONFUSION, DIFFICULTY SPEAKING, DIAPHORESIS, AND SHAKINESS. THE PATIENT REPORTEDLY DID NOT REQUIRE ASSISTANCE FROM A THIRD PARTY AND DID NOT RECEIVE ANY TREATMENT ABOVE OR BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. THE REPORTER ALLEGED AN INACCURATE DELIVERY ISSUE WITH THE PUMP. THE REPORTER STATED THEY BELIEVE THE PUMP WAS EITHER BOLUSING THE PATIENT ON ITS OWN OR THE PUMP WAS RANDOMLY GIVING THE PATIENT INSULIN. TROUBLESHOOTING PERFORMED BY ANIMAS CUSTOMER TECHNICAL SUPPORT EXAMINED THE TOTAL DAILY DOSE AND THE BOLUS HISTORY AS WELL AS THE PRIME HISTORY AND DID NOT REVEAL ANY EVIDENCE INDICATING THAT THE PUMP RANDOMLY INFUSED THE PATIENT WITH INSULIN THAT IT WAS NOT PROGRAMMED TO GIVE. IT WAS DISCOVERED THAT THE BASAL RATE SETTING IN THE PUMP HAD BEEN ADJUSTED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A SERIOUS INJURY ON INSULIN PUMP THERAPY ASSOCIATED WITH USE ERROR. NOT PUMP MALFUNCTION WAS IDENTIFIED THROUGH TROUBLESHOOTING.
Patient problems: Confusion/ Disorientation; Diaphoresis; Hypoglycemia
MAUDE report 6183822 ↗InjuryOct 17, 2016Inaccurate Delivery; Inaccurate Delivery
ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE OF 11 MG/DL ASSOCIATED WITH AN INACCURATE DELIVERY ISSUE. REPORTEDLY, THE PATIENT DISCONTINUED THE INSULIN PUMP, EMERGENCY PROTOCOL WAS INITIATED AND THE PATIENT WAS TREATED BY EMS WITH GLUCAGON INJECTION. TROUBLESHOOTING WAS UNABLE TO BE COMPLETED AT THE TIME OF THE CALL. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION AGAINST THE DELIVERY FUNCTION OF THE PUMP.
Patient problems: Hypoglycemia
MAUDE report 6033562 ↗
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- Accu-Chek Combo 05027250001Roche Diabetes Care GmbH · Pump, Infusion, Insulin1,830 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.