BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA

    MDR report key: 1844374 · Received September 24, 2010

    Report

    Report Number
    2954323-2010-01330
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    August 24, 2010
    Report Date
    December 30, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: CUSTOMER'S METER SN ((B)(4)) WAS RETURNED. THE COMPLAINT IS CONFIRMED. THE INVESTIGATION NOTED THE METER POWERED ON WITH BUTTON DEPRESSION AND WHEN A TEST STRIP WAS INSERTED ERROR-7 WAS OBSERVED. THE METER HAS BEEN SENT FOR AN EXTENDED INVESTIGATION.

    Additional Manufacturer Narrative · 1

    RESULTS: THE CUSTOMER'S METER (B)(4) WAS RETURNED AND INVESTIGATED. UPON EXTENDED PRODUCT INVESTIGATION THE "E-7" ERROR MESSAGE WAS CONFIRMED. THE INVESTIGATION DETERMINED THE ROOT CAUSE OF THE ERRC-7 ISSUE WAS A FAILURE OF THE ELECTROSTATIC DISCHARGE (ESD) SUPPRESSOR. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A READINGS ISSUE ON THEIR ADC METER WHILE USING AN AFFECTED TEST STRIP LOT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM LFS CUSTOMER SERVICE. THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) CUSTOMER SERVICE ON (B)(6) 2010 ALLEGING THAT THE USER'S GUIDE OF THE ONETOUCH ULTRA2 METER IS TOO BIG AND NOT USER FRIENDLY. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION OF METFORMIN AND GLIPIZIDE. THE PATIENT EXPERIENCED THE ISSUE ON (B)(6) 2010 AT 7 PM. THERE WAS NO ALTERATION TO HER DIABETES BASED ON THE ALLEGED ISSUE. THE PATIENT CLAIMED THAT BECAUSE THE FOLD OUT INSTRUCTIONS IS TOO BIG TO USE OR TAKE WITH HER, SHE WAS UNABLE TO UTILIZE THE INSTRUCTION TO OPERATE THE LFS METER. AT 7:30 PM, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS DESCRIBED AS "HEADACHE AND SWEATY" DUE TO THE USER'S GUIDE ISSUE. THERE WAS NO ALLEGATION OF TREATMENT FOR ACUTE COMPLICATION OF DIABETES AS RESULT OF THE PRODUCT ISSUE. IT WOULD HAVE BEEN HELPFUL TO HAVE MORE DETAILS CONCERNING THE PATIENT'S DIABETES REGIMEN AND THE CIRCUMSTANCES SURROUNDING THE INCIDENT. ACCORDING TO THE TROUBLESHOOTING PERFORMED WITH CUSTOMER SERVICE, THE SUBJECT METER WAS REPLACED WITH THE ONETOUCH ULTRA METER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIA DUE TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    A "TECHNICIAN" REPORTED THAT ON (B)(6) 2010 A CUSTOMER RECEIVED AN E-7 MESSAGE ON THE DISPLAY OF HIS PRECISION XTRA BLOOD GLUCOSE METER UPON INSERTION OF A GLUCOSE TEST STRIP. IT WAS FURTHER REPORTED THAT A COUPLE OF DAYS LATER, ON (B)(6) 2010, HE SELF-PRESENTED TO HIS HEALTHCARE PROVIDER AND WHILE AT THE OFFICE EXPERIENCED A LOSS OF CONSCIOUSNESS. CUSTOMER DID NOT RECEIVE A DIAGNOSIS, BUT WAS TREATED WITH ORANGE JUICE. HE THEN HAD HIS GLUCOSE CHECKED ON THE HEALTHCARE PROVIDER'S METER AND RECEIVED A READING OF 183 MG/DL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM NBW 45721

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R