BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA MINI METER

    MDR report key: 1060354 · Received June 17, 2008

    Report

    Report Number
    2939301-2008-01070
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 16, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET REC'D THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY PT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONE TOUCH ULTRA MINI METER READ INACCURATELY LOW. THE MEDICAL AFFAIRS SPECIALIST (MAS) SENT F/U QUESTIONS TO LFS CANADA AND REC'D ANSWERS INCLUDED BELOW. THE PT TAKES 30 UNITS OF HUMULIN N INSULIN AT 9:00 AM AND 6:00 PM DAILY. HE ALSO TAKES HUMALOG INSULIN BY SLIDING SCALE AT EVERY MEAL; HE SAID HE NEVER TAKES MORE THAN 14 UNITS, BUT HE DID NOT PROVIDE MORE INFO REGARDING THE SLIDING SCALE REGIMEN. THE PT FELT TIRED, ILL, IRRITABLE, AND HAD BLURRED VISION THE AFTERNOON OF THE SAME MONTH. HE DID NOT KNOW THE SPECIFIC METER READINGS HE HAD OBTAINED PRIOR TO HAVING SYMPTOMS; HOWEVER, THE METER HAD READ SIMILARLY, IN THE 7.0 MMOL/L RANGE, TO THE READING OF 7.5 MMOL/L HE OBTAINED ON THE REPORTED METER WHILE SYMPTOMATIC. HE SAID, HE WOULD HAVE TAKEN MEDICATION AS REGULAR (USUAL) BASED ON HIS METER READINGS PRIOR TO HAVING SYMPTOMS. ONE MINUTE AFTER HE OBTAINED THE 7.5 MMOL/L READING ON THE REPORTED METER, HE OBTAINED A READING OF 24.9 AND 25.1 MMOL/L ON A FRIEND'S METER, USING THE PT'S TEST STRIPS FOR THE 24.9 READING AND THE FRIEND'S TEST STRIPS FOR THE 25.1 MMOL/L READING. THE PT REPEATED A TEST WITH THE REPORTED METER; THE RESULT WAS 7.6 MMOL/L. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE BETWEEN THE TWO METERS' READINGS EXCEEDS THE EXPECTED VALUE OF <=30% AND/OR <=1.7 MMOL/L. AT THAT TIME, THE PT TOOK 13 UNITS OF HUMALOG INSULIN AND DRANK 8 LITERS OF WATER AS HIS HEALTH CARE PROFESSIONAL (HCP) HAD ADVISED IN THE PAST FOR TREATMENT OF HYPERGLYCEMIA. HE DID NOT CONTACT HIS HCP ON THE NEXT DAY BECAUSE HE DOES NOT HAVE HEALTH COVERAGE AND DID NOT WANT TO SPEND THE MONEY. THREE HRS LATER, THE PT OBTAINED A RESULT OF 14.5 MMOL/L ON THE FRIEND'S METER. HE TOOK 12 UNITS ADD'L HUMALOG INSULIN. TWO HRS LATER, HE OBTAINED A READING OF 4.8 MMOL/L ON THE FRIEND'S METER. THE LFS CUSTOMER SVC REP (CSR) NOTED THAT REPORTED METER READ OUTSIDE OF SPECS WITH CONTROL SOLUTION. THE CSR NOTED THE PT'S OLD TEST STRIP LOT WAS USED UP. THE PT'S PRODS WERE REPLACED. THE COMPLAINT IS REPORTED BECAUSE THE PT ALLEGES HE TOOK INSULIN BASED ON INACCURATE LOW READINGS ON THE LFS PROD AND AFTERWARD DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH HYPERGLYCEMIA AND HYPERGLYCEMIC READINGS ON ANOTHER METER. THE PT CLAIMS HE TREATED HIMSELF WITH ADD'L INSULIN AND ORAL FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA MINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Life Threatening