BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PING METER

    MDR report key: 2062856 · Received April 19, 2011

    Report

    Report Number
    2939301-2011-03214
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    November 18, 2010
    Report Date
    April 4, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. 510(K) # IS K082590.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (05/11/2011)-DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER¿S LCD WAS FOUND TO BE DEFECTIVE. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH PING METER HAD A LINE THROUGH THE DISPLAY. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE LAY USER/PATIENT ON (B)(6) 2011 AND OBTAINED THE FOLLOWING INFORMATION: THE PATIENT TESTS SEVEN TO TEN TIMES A DAY AND MANAGES HER DIABETES WITH INSULIN (VIA INSULIN PUMP). THE PATIENT ALLEGED THAT THE ISSUE BEGAN BETWEEN (B)(6) 2010. DESPITE THE PRODUCT ISSUE, THE PATIENT STATED SHE CONTINUED TO MONITOR HER BLOOD GLUCOSE WITH THE SUBJECT METER. THE PATIENT INDICATED SHE HAS A SECONDARY/ BACK-UP METER; HOWEVER, THE PATIENT CLARIFIED SHE WOULD ONLY USE HER SECONDARY METER WHEN SHE IS OUTDOORS. PER THE PATIENT, SHE WAS ABLE TO VIEW THE FIRST TWO NUMBERS OF THE DISPLAY; HOWEVER, AS A RESULT OF THE ALLEGED ISSUE, SHE WAS UNABLE TO CLEARLY READ THE THIRD DIGIT. AFTER OBTAINING A READING WITH THE SUBJECT METER, THE PATIENT CLARIFIED SHE ADMINISTERED HER INSULIN BASED ON THE ASSUMPTION WHAT THE COMPLETE READING WAS. ON (B)(6) 2010, WHILE VACATIONING IN (B)(6), THE PATIENT CLAIMED SHE BECAME UNCONSCIOUS. THE PATIENT DOES NOT RECALL HER BLOOD GLUCOSE RESULT PRIOR TO THE ONSET OF HER SYMPTOM NOR DOES SHE RECALL WHAT ACTION SHE TOOK IN RESPONSE TO HER PREVIOUS BLOOD GLUCOSE READING. WITH THE ASSISTANCE FROM HER SIGNIFICANT OTHER, THE PATIENT INDICATED SHE WAS BROUGHT TO THE HOSPITAL (IN (B)(6)). THE PATIENT INDICATED WHEN SHE REGAINED CONSCIOUSNESS (DATE/TIME NOT KNOWN) SHE WAS TOLD BY A HEALTH CARE PROFESSIONAL (HCP) THAT SHE HAD OBTAINED A READING OF "100MG/DL" WITH THE HOSPITAL'S METER AND THAT SHE WAS SUFFERING FROM "DOUBLE PNEUMONIA" AND LOW BLOOD GLUCOSE. DURING HER TIME IN THE HOSPITAL THE PATIENT STATED SHE WAS ADMINISTERED IV FLUIDS AND OTHER UNKNOWN MEDICATIONS. ACCORDING TO THE PATIENT, SINCE THE DOCTORS AND NURSES WERE NOT FAMILIAR WITH THE SUBJECT METER AND HER INSULIN PUMP, SHE WAS PERMITTED DURING HER HOSPITAL STAY TO CONTINUE TO TEST WITH THE SUBJECT METER (DESPITE THE ALLEGED ISSUE) AND CONTINUE TO SELF ADMINISTER HER OWN INSULIN (BASED ON HER ASSUMPTION ON WHAT THE RESULT WAS ON THE SUBJECT METER). THE PATIENT INDICATED SHE WAS HOSPITALIZED FOR FOUR TO FIVE DAYS. WHEN THE PATIENT RETURNED HOME FROM HER VACATION IN (B)(6), THE PATIENT CONTINUED TO MONITOR HER BLOOD GLUCOSE WITH THE SUBJECT METER. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THERE WAS NO MISUSE OF THE LFS PRODUCT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT CONTINUED TO MONITOR HER BLOOD GLUCOSE WITH THE SUBJECT METER (DESPITE THE ALLEGED ISSUE) AND ADMINISTER HER INSULIN ON THE ASSUMPTION WHAT THE RESULT WAS, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R