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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANIMAS CORPORATION ONETOUCH PING - INSULIN PUMP; GLUCOSE OXIDASE, GLUCOSE
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ANIMAS CORPORATION ONETOUCH PING - INSULIN PUMP; GLUCOSE OXIDASE, GLUCOSE Back to Search Results
Medical Device Problem Code Obstruction of Flow (2423)
Health Effect - Clinical Codes Hyperglycemia (1905); Loss of consciousness (2418)
Date of Event 10/15/2011
Type of Reportable Event Serious Injury
Event or Problem Description
In accordance with 21 cfr 803.22 (b)(2), we are notifying you that on (b)(6) 2012, a customer's husband contacted roche diagnostics and reported an event that occurred on (b)(6) 2011.The customer's husband tried to awaken her, but she was not responsive so he called an ambulance.Husband tested her with the accu-chek compact plus meter and kept getting hi, which on the system indicates a result in excess of 600 mg/dl.The ambulance transported her to a hospital, where a lab test result was 995 mg/dl.She was admitted for a week.The customer was using a one touch ping insulin pump at the time.Her husband stated that the infusion was blocked and not giving her insulin and that is why she became hyperglycemic.The one touch ping insulin pump mentioned in this event is not manufactured or imported by our firm.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
ONETOUCH PING - INSULIN PUMP
Common Device Name
GLUCOSE OXIDASE, GLUCOSE
Manufacturer (Section D)
ANIMAS CORPORATION
MDR Report Key17534822
Report NumberMW5141721
Device Sequence Number6171139
Product Code CGA
Combination Product (Y/N)N
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Voluntary
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 01/14/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/12/2023
Patient Sequence Number1
Patient SexUnknown
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