OneTouch Ping 10143400Recalls & reported problems
Animas Corporation · Rev Kit, OTP, PGL, mg/DL, US · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10840406100822), received between Oct 11, 2016 and Oct 23, 2017 — classified as 4 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
- Appropriate Device Problem Term/Code Not Available1
- Date/Time-Related Software Problem1
- Device Issue1
- Failure to Prime1
- Use of Device Problem1
Patient problems
- Hyperglycemia2
- Abdominal Pain1
- Hypoglycemia1
- No Consequences Or Impact To Patient1
- No Information1
- Urinary Frequency / Polyuria1
- Vomiting1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryOct 23, 2017Date/Time-Related Software Problem; Date/Time-Related Software Problem
ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS ALLEGING THE PATIENT'S BLOOD GLUCOSE THAT DAY WAS 597 MG/DL WITH EXCESS URINATION. IT WAS REPORTED THE PATIENT DISCONTINUED PUMP THERAPY AND THE DELIVERY SETTINGS WERE NOT CHANGED RECENTLY. REPORTEDLY THE PATIENT RECEIVED PHONE ADVICE TO SELF-TREAT WITH INSULIN VIA INJECTION. IT WAS REPORTED THAT THE PUMP'S TIME SETTING RESET TO DEFAULT WHEN THE BATTERY WAS REMOVED FOR LESS THAN 24 HOURS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ADVERSE EVENT WAS ATTRIBUTED TO A DEVICE MALFUNCTION.
Patient problems: Hyperglycemia; Urinary Frequency / Polyuria
MAUDE report 6970821 ↗InjuryAug 16, 2017Use of Device Problem; Use of Device Problem
ON (B)(6) 2017, THE REPORTER CONTACTED ANIMAS, ALLEGING THE PATIENT¿S BLOOD GLUCOSE (BG) ON (B)(6) 2017 WAS 1300 MG/DL WITH LARGE KETONES, ABDOMINAL PAIN, NAUSEA, AND VOMITING. THE REPORTER NOTED THE PATIENT WAS HOSPITALIZED AND TREATED WITH INTRAVENOUS FLUIDS AND INSULIN DRIP, THEY REMAINED ON PUMP THERAPY WITH REPLACEMENT, AND THE PUMP¿S DELIVERY SETTINGS WERE NOT RECENTLY CHANGED BY A HEALTHCARE PROVIDER. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THE PUMP WAS PROGRAMMED WITH ONLY ONE BASAL PROGRAM. IT WAS REPORTED THAT THE PUMPS BASAL HISTORY AND TOTAL DAILY DOSE BASAL HISTORY WERE APPROPRIATE FOR THE PROGRAMED BASAL RATES; THE BOLUS HISTORY MATCHED THE TOTAL DAILY DOSE BOLUS HISTORY; THE BOLUS HISTORY RECORDED WAS ACCURATE AS PROGRAMED; THE PUMP WAS CALCULATING RECOMMENDED BOLUS TOTALS CORRECTLY. THERE WAS NO INDICATION OF A DEVICE MALFUNCTION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED HEALTH EVENT WAS ATTRIBUTED TO A DEVICE USE ERROR.
Patient problems: Abdominal Pain; Hyperglycemia; Vomiting
MAUDE report 6796993 ↗InjuryNov 17, 2016Failure to Prime; Failure to Prime
ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS ALLEGING THE PATIENT WAS VOMITING AT TIME OF THE CALL. A 911 PROTOCOL REPORTEDLY WAS INITIATED. THE PUMP REPORTEDLY HAD A NO DELIVERY MESSAGE-PUMP NOT PRIMED MESSAGE. ANIMAS CUSTOMER TECHNICAL SUPPORT REPORTEDLY ATTEMPTED TO CONTACT THE REPORTER MULTIPLE TIMES WITHOUT RESOLVE. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE FOR THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED AN ADVERSE EVENT ALLEGEDLY DUE TO A LOSS OF PRIME ISSUE WITH THE DEVICE.
Patient problems: No Information
MAUDE report 6108997 ↗MalfunctionOct 28, 2016Device Issue; Device Issue
ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING THAT THE PUMP WAS NOT ALARMING PROPERLY. THERE WAS NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. CUSTOMER SUPPORT HAS MADE SEVERAL ATTEMPTS TO CONTACT THE REPORTER IN FOLLOW UP, HOWEVER, THE REPORTER DID NOT RESPOND. NO FURTHER INFORMATION WAS AVAILABLE; IF FURTHER INFORMATION IS PROVIDED A FOLLOW UP REPORT SHALL BE MADE. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE ALLEGATION OF AN UNSPECIFIED PUMP ALARM MALFUNCTION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6065580 ↗InjuryOct 11, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON (B)(6) 2016, THE PATIENT HAD A BLOOD GLUCOSE LOWER THAN 20 MG/DL, WITH COGNITIVE IMPAIRMENT. THE PATIENT WAS TREATED IN THE EMERGENCY ROOM WITH IV GLUCOSE. DURING TROUBLESHOOTING, CUSTOMER SUPPORT FOUND THAT THE TIME AND DATE RESET TO DEFAULT WHEN THE BATTERY WAS REMOVED FROM THE PUMP FOR LESS THAN 24 HOURS. THE TIME AND DATE ISSUE COMPLAINT IS NOT BEING REPORTED BASED ON THE FOLLOWING: THE PUMP DISPLAYS THE VERIFY SCREEN AFTER IT IS REBOOTED AND THE TIME AND DATE MUST BE SET TO CONFIRM THE VERIFY SCREEN. THIS COMPLAINT IS BEING REPORTED AS CS ATTRIBUTED THE HYPOGLYCEMIA TO USE ERROR.
Patient problems: Hypoglycemia
MAUDE report 6016658 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.