BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREESTYLE PRECISION H

    MDR report key: 3262957 · Received August 5, 2013

    Report

    Report Number
    2954323-2013-00422
    Event Type
    Death
    Date Received
    August 5, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 4, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. NOTE: THE DATE OF PATIENT'S DEATH IS UNKNOWN, THE EVENT DATE ENTERED IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THIS MEDICAL EVENT. NOTE: THE METER'S MANUFACTURE DATE IS UNKNOWN, THE DEVICE MANUFACTURE DATE ENTERED IS THE DATE WHEN ABBOTT DIABETES CARE BECAME AWARE OF THIS MEDICAL EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE. FOR EACH OF THE REPORTED DEATHS, THE HOSPITAL DID NOT PROVIDE ANY CLINICAL INFORMATION, SUCH AS THE CUSTOMER SYMPTOMS, READINGS OR TREATMENT, IF ANY, AND RELATIVE TIME AND DATES. THE HOSPITAL RETURNED THE FOLLOWING PRODUCTS: METER SERIAL NUMBERS- (B)(4); AND TEST STRIPS LOT NUMBERS 4500161200AND 4500161313. HOWEVER, BASED ON THE INFORMATION PROVIDED, IT IS UNCLEAR WHETHER OR NOT THE RETURNED PRODUCTS WERE ASSOCIATED WITH THE 5 REPORTED DEATHS. FOR THE PRODUCTS RETURNED, INVESTIGATION DETERMINED THE COMPLAINT IS NOT CONFIRMED AND ALL RETURNED PRODUCTS WERE FOUND TO BE WITHIN SPECIFICATION. IT SHOULD BE NOTED THAT DURING ATTEMPTS TO OBTAIN CLARIFICATION, IT WAS REVEALED THAT NOT ALL OF THE METERS WERE CALIBRATED AND THAT THE DIFFERENT WARDS WITHIN THE HOSPITAL WERE SHARING METERS. LABEL COPY PROVIDES INSTRUCTIONS FOR USERS ON HOW ON CALIBRATE THE METER AND THAT DOING SO ALLOWS THE METER TO RECOGNIZE THE TEST STRIP BEING USED AND TO ENSURE THE RESULTS ARE ACCURATE.

    Additional Manufacturer Narrative · 1

    ALTHOUGH FURTHER DETAILS SURROUNDING THE DEATH CASES THAT WERE PREVIOUSLY REPORTED HAVE BEEN UNSUCCESSFUL, ADC HAS LEARNED THAT THE MEDICAL PERSONNEL AT THE REPORTING HOSPITAL HAVE BEEN RETRAINED AND THAT A MORE ROBUST PROTOCOL HAS BEEN IMPLEMENTED. THE TRAINING EMPHASIZED THE NEED AND IMPORTANCE OF WHEN TO CALIBRATE THE METER AND THE PURPOSE OF DOING SO, BOTH OF WHICH ARE MENTIONED IN LABEL COPY. IT WAS ALSO REPORTED THAT THE HOSPITAL'S ROUTINE HABIT OF SWAPPING METERS AMONGST THE DIFFERENT WARDS IS NO LONGER BEING PRACTICED. IN ADDITION, THE METERS INVOLVED OR WHICH THE REPORT FROM THE HOSPITAL IDENTIFIED AS HAVING BEEN INVOLVED, HAVE ALL BEEN REPLACED. DURING SUBSEQUENT FOLLOW-UP ATTEMPTS THE HOSPITAL NURSE NOTIFIED ADC THAT THERE WERE MORE THAN FIVE DEATHS AS RESULT OF HYPOGLYCEMIA, BUT SHE DID NOT PROVIDE ANY FURTHER SPECIFICS OR IMPLY THAT THESE ADDITIONAL DEATHS WERE RELATED TO THE USE OF AN ADC DEVICE. ADC HAS BEEN INFORMED THERE WERE POTENTIALLY TWENTY FIVE METERS WHICH MAY OR MAY NOT HAVE BEEN RELATED TO THE REPORTED DEATHS. ALTHOUGH NOT ALL PRODUCTS POTENTIALLY RELATED TO THIS EVENT HAVE BEEN RETURNED, INVESTIGATION HAS BEEN PERFORMED ON THOSE PRODUCTS THE HOSPITAL IMPLIED AS BEING EVENT RELATED. TO DATE, ADC HAS INVESTIGATED THE THREE METERS MENTIONED IN THE INITIAL MDR AS WELL AS TWO TEST STRIP LOTS: 4500161200 AND 4500161313. AS COMMUNICATED PREVIOUSLY IN THE INITIAL MDR, INVESTIGATION SHOWED THAT ALL THREE METERS RETURNED PERFORMED ACCORDING TO SPECIFICATION AND RETAIN TESTING FOR LOT NUMBER 4500161313 WAS FOUND TO BE SATISFACTORY. IN ADDITION, A DHR REVIEW WAS PERFORMED FOR BOTH LOTS AND NO ISSUES WERE IDENTIFIED. RETAIN TESTING RESULTS FOR BOTH HIGH AND LOW LEVEL WERE WITHIN SPECIFICATION FOR LOT NUMBER 4500161200 AND VISUAL INSPECTION OF RETAIN TEST STRIPS FROM BATCH 4500161200 DID NOT IDENTIFY ANY DEFECTS OR ISSUES. IN ADDITION, WHOLE BLOOD TESTING FOR THIS RETAIN WAS CONDUCTED AND 100% OF THE RESULTS WERE IN ZONE A OF THE CONSENSUS ERROR GRID. GIVEN THE INITIAL COMPLAINTS DID NOT INCLUDE A COMPLETE LISTING OF ALL METER SERIAL NUMBERS AND/OR TEST STRIPS, ADC IS NOT ABLE TO CONFIRM THE REPORTED EVENTS. THIS IS COMPOUNDED BY THE FACT THAT NOT ALL PRODUCTS WHICH ARE POTENTIALLY RELATED TO THE EVENT HAVE BEEN RETURNED. THERE IS NO INDICATION FROM THE HOSPITAL THAT ANY ADDITIONAL PRODUCTS OR RELATED DETAILS ARE FORTHCOMING. HOWEVER, ADC WOULD SUBMIT A SUPPLEMENTAL MDR PER 21 CFR 803.56 SHOULD ANY NEW OR CORRECTED INFORMATION BE OBTAINED. ALL PERTINENT INFORMATION KNOWN TO ADC HAS BEEN SUBMITTED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    WHILE ADC INITIALLY REPORTED THERE WERE POTENTIALLY 25 METERS INVOLVED, CORRESPONDENCE WITH THE AFFILIATE HAS CONFIRMED ALL METERS RELATED TO THE HOSPITAL'S COMPLAINT HAVE BEEN RETURNED AND INVESTIGATED; THEREFORE, A TOTAL OF 11 METERS WERE INVOLVED. ADC RECEIVED THE FOLLOWING EIGHT ADDITIONAL METERS THAT WERE MANUFACTURED EITHER IN DECEMBER 2012 OR JUNE 2012 : XCMS347-P1043 (DEC 2012), XCMS347-P11A8 P1043 (DEC 2012), XCMS347-P1031 P1043 (DEC 2012), XCMS167-P1B9B9 (JUN 2012), XCMS167-P1AB1 (JUN 2012), XCMS167-P1E02 (JUN 2012), XCMS167-P1BB4 (JUN 2012), XCMS167-P1EEA (JUN 2012). ALL EIGHT RETURNED METERS WERE INVESTIGATED WITH CONTROLLED TEST STRIPS AND NONE WERE CONFIRMED FOR A READINGS ISSUE RELATED TO BLOOD GLUCOSE READINGS. HOWEVER, UPON INVESTIGATION ONE METER (XCMS347-P1031) WAS CONFIRMED FOR A BLACK SPOT ON THE LIQUID CRYSTAL DISPLAY (LCD). THE METER WAS DISASSEMBLED AND DAMAGED WAS OBSERVED ON THE LCD. THE ADC SALES REPRESENTATIVE STATED ALL THIRTY-SIX STAFF MEMBERS AT THE HOSPITAL RECEIVED RE-TRAINING FROM AN ADC REPRESENTATIVE ON THE PRODUCT. THE ADC SALES REPRESENTATIVE USED A DEMO KIT IN CONJUNCTION WITH PRODUCT LABELING TO DEMONSTRATE THE DIFFERENT FUNCTIONS OF THE METER SUCH AS METER CALIBRATION AND BLOOD GLUCOSE TESTING. ALL METERS HAVE BEEN REPLACED WITH NEW BATTERIES AND EVERY METER HAS BEEN PRE-SET WITH DATE AND TIME BY THE SALES REPRESENTATIVE. THERE WERE NO NEW ISSUES WITH THE NEW METERS AND NO ADDITIONAL DETAILS ARE KNOWN REGARDING THE REPORTED DEATHS. NOTE: ON THE PREVIOUS SUBMITTED MDRS THE BRAND NAME AND CATALOG # WERE INCORRECT. THE CORRECT BRAND NAME IS FREESTYLE PRECISION H AND CATALOG # IS 71181-70.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) NOTIFIED AN ABBOTT DIABETES CARE (ADC) REPRESENTATIVE THAT DURING A MORTALITY AND MORBIDITY MEETING HELD ON (B)(6) 2013 IT WAS "REVEALED THAT 5 PATIENTS HAD DIED AS A RESULT OF HYPOGLYCEMIA". THE HOSPITAL FURTHER REPORTED THAT ADC METERS WERE "INACCURATE". HOWEVER, THE ADC REPRESENTATIVE WAS UNABLE TO OBTAIN ANY FURTHER CLARIFICATION OR SPECIFICS REGARDING THE REPORTED DEATHS OR EXACTLY HOW THE ADC METERS WERE REPORTEDLY READING INACCURATELY. THE REPORTS WERE ALSO VOID OF ANY PATIENT DETAILS, SUCH AS THE PATIENTS' ADMITTING DIAGNOSIS, PRE-EXISTING MEDICAL CONDITIONS, OR OTHER PERTINENT CLINICAL BASELINE PATIENT INFORMATION. IN ADDITION, THE REPORT DID NOT MENTION ANY SPECIFIC READINGS OR RESULTS FROM AN ADC METER AND DID NOT PROVIDE A TIME LINE OR CHRONOLOGY OF EVENTS. ALTHOUGH THE REPORT DOES NOT OBJECTIVELY PROVIDE ASSOCIATION BETWEEN THE DEATHS AND THE USE OF AN ADC DEVICE, ADC'S DECISION TO FILE IS BASED ON THE NUMBER OF DEATHS REPORTED. THIS IS FIRST MDR IN THE SERIES OF 6 DEATHS MDRS FROM THE SAME HOSPITAL IN (B)(6). FIVE OF THE DEATH MDRS HAVE NO SPECIFIC EVENT DETAILS AND ATTRIBUTE THE OUTCOME TO HYPOGLYCEMIA, WHEREAS THE SIXTH EVENT INVOLVED A DEATH WITH UNKNOWN CAUSE THAT OCCURRED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365555 FREESTYLE PRECISION H BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 Death