BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUERESULT

    MDR report key: 8651292 · Received May 29, 2019

    Report

    Report Number
    1000113657-2019-00564
    Event Type
    Injury
    Date Received
    May 29, 2019
    Date of Event
    April 29, 2019
    Report Date
    January 7, 2020
    Manufacturer
    TRIVIDIA HEALTH, INC.
    Product Code
    NBW
    PMA / PMN Number
    K080641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT#: (B)(4). ADDITIONAL INFORMATION: TRIVIDIA CONSULTED AN INDEPENDENT MEDICAL EXPERT TO REVIEW THE COMPLAINT AND THE COMPLAINANT'S MEDICAL RECORDS. BASED ON THAT REVIEW, TRIVIDIA SUBMITS THIS FOLLOW UP MDR. THE COMPLAINANT HAD POORLY CONTROLLED DIABETES DURING THE FIRST TRIMESTER OF HER PREGNANCY. HOWEVER, THERE IS NO EVIDENCE THAT SHE WAS TESTING HER BLOOD GLUCOSE DURING THE FIRST TRIMESTER AND NO EVIDENCE THAT SHE WAS USING TRIVIDIA STRIPS. BASED ON HER HBA1C READING ON (B)(6) 2016 (DISCUSSED BELOW), IT IS CLEAR SHE WAS EXPERIENCING HIGH BLOOD GLUCOSE DURING THE PRIOR THREE MONTHS. EVEN THOUGH HYPERGLYCEMIA IN THE FIRST TRIMESTER CAN BE CLINICALLY SIGNIFICANT, THAT HIGH BLOOD SUGAR DID NOT NECESSARILY LEAD TO CONGENITAL ABNORMALITIES. THE RECORDS INDICATE THAT SHE STARTED USING THE TEST STRIPS AFTER HER FIRST PRE-NATAL VISIT ON (B)(6) 2016 AFTER WHICH HER BLOOD GLUCOSE CONTROL DRAMATICALLY IMPROVED AS EVIDENCED BY HER ON (B)(6) 2016 HBA1C READING. THIS INDICATES THAT THE TEST STRIPS WERE MORE THAN LIKELY WORKING PROPERLY. THE MEDICAL EXPERT CITES SMOKING, OBESITY, HYPERTENSION AND MEDICATIONS AS BEING FACTORS THAT RESEARCHERS LINK TO THE BIRTH DEFECTS EXPERIENCED BY THE COMPLAINANT'S DAUGHTER. IN PARTICULAR, THE MEDICAL RECORDS INDICATE THAT COMPLAINANT SMOKED THROUGHOUT HER PREGNANCY. ACCORDING TO THE EXPERT, THE ASSOCIATION OF CONGENITAL ABNORMALITIES AND MATERNAL SMOKING DURING PREGNANCY IS NOW ACCEPTED AND ADOPTED BY THE SURGEON GENERAL. THE MOST RECENT SURGEON GENERAL REPORT CONCLUDES THAT SMOKING CAUSES "CLEFT LIP AND CLEFT PALATES IN BABIES OF WOMEN WHO SMOKE DURING EARLY PREGNANCY." HTTPS://WWW.HHS.GOV/SURGEONGENERAL/REPORTS-AND-PUBLICATIONS/TOBACCO/CONSEQUENCES-SMOKING-FACTSHEET/INDEX.HTML AND THE REPORT UPDATES ITS POSITION ON SUCH IMPACTS TO FETUSES: "THE EVIDENCE IS SUFFICIENT TO INFER A CAUSAL RELATIONSHIP BETWEEN MATERNAL SMOKING IN EARLY PREGNANCY AND OROFACIAL CLEFTS." SEE TABLE 4.4 PAGE 83 AND PAGE 119. THE FULL REPORT CAN BE FOUND AT: HTTPS://WWW.NCBI.NLM.NIH.GOV/BOOKS/NBK179276/PDF/BOOKSHELF_NBK179276.PDF. BASED ON THIS INFORMATION, TRIVIDIA CONSIDERS THAT EVEN IF THE COMPLAINANT WERE USING TRIVIDIA STRIPS THAT ERRONEOUSLY DOCUMENTED NORMAL OR LOW BLOOD SUGAR READINGS, THE DEFECTS IDENTIFIED IN THE INFANT CANNOT BE ATTRIBUTED TO THE USE OF THE STRIPS.

    Description of Event or Problem · 0

    CONSUMER CALLED ABOUT THE TRUERESULT PRODUCTS. CUSTOMER CALLED REGARDING AN EVENT THAT ALLEGEDLY TOOK PLACE OVER 3 YEARS AGO (2016). CUSTOMER INDICATED THAT, IN 2016, SHE WENT INTO PRETERM LABOR (34 WEEKS) AND HER BABY WAS BORN WITH MULTIPLE BIRTH DEFECTS. CUSTOMER INDICATED THAT HER DAUGHTER IS NOW 3 YEARS OLD AND HAS PICA. CUSTOMER STATED THAT SHE USED TEST STRIPS DURING HER PREGNANCY AND WAS CONCERNED THAT THE TEST STRIPS THAT SHE WAS USING DURING HER PREGNANCY IN 2016 WERE RECALLED. CUSTOMER STATED THAT SHE READ THE RECALL LETTER AND IT INDICATED THAT THE METER GAVE LOWER RESULTS. CUSTOMER STATED THAT HER GLUCOSE LEVEL WAS HIGHER DURING PREGNANCY. CUSTOMER BELIEVES THAT HER PREGNANCY WAS AFFECTED BECAUSE SHE BELIEVES THE STRIPS WERE PART OF THE RECALL. CUSTOMER DID NOT PROVIDE ANY IDENTIFYING INFORMATION REGARDING THE SPECIFIC PRODUCTS ALLEGEDLY USED IN 2016. CUSTOMER DID NOT REPORT THAT SHE WAS CURRENTLY EXPERIENCING ANY SYMPTOMS OR REQUIRED ANY MEDICAL ATTENTION DURING ON (B)(6) 2019 CALL.

    Additional Manufacturer Narrative · 1

    (MANUFACTURER NARRATIVE = T, CORRECTED DATA = F) INTERNAL REPORT: # (B)(4). NOTE: MANUFACTURER WAS ABLE TO LOCATE ANOTHER RECORD FROM THE SAME CUSTOMER WHICH REFLECTS THAT THE CUSTOMER PREVIOUSLY CALLED IN TO INQUIRE ABOUT TEST STRIPS (INTERNAL REPORT # (B)(4) ON 08/23/2018). DURING THE 2018 CALL, THE PRODUCT AT ISSUE WAS IDENTIFIED AS TRUERESULT, METER SERIAL #: (B)(4), TEST STRIP LOT #: PS2592. IN 2018, THE CUSTOMER WAS INFORMED THAT THE TRUERESULT PRODUCTS WERE DISCONTINUED AND THE CUSTOMER WAS ASKED TO STOP THE USE OF ANY DISCONTINUED PRODUCTS. AT THAT TIME, THE CUSTOMER PRODUCTS WERE REPLACED WITH TRUE METRIX (METER, TEST STRIPS AND CONTROL SOLUTION) AND A PREPAID ENVELOPE WAS SENT TO RETURN DISCONTINUED PRODUCTS TO THE MANUFACTURER. AT THE TIME OF THE 2018 CALL, THE CUSTOMER DID NOT REPORT ANY ADVERSE EVENTS OR SERIOUS INJURY RELATED TO USE OF THE PRODUCTS. THE PRODUCT RETURNED IN 2018 WAS CROSS-REFERENCED AND DETERMINED TO NOT BE PART OF THE RECALLED PRODUCTS. ACCORDINGLY, SINCE NO ADVERSE EVENTS WERE REPORTED AND THE PRODUCT WAS NOT SUBJECT TO THE RECALL, NO FURTHER INVESTIGATION WAS NECESSARY.

    Description of Event or Problem · 1

    CONSUMER CALLED ABOUT THE TRUERESULT PRODUCTS. CUSTOMER CALLED REGARDING AN EVENT THAT ALLEGEDLY TOOK PLACE OVER 3 YEARS AGO (2016). CUSTOMER INDICATED THAT, IN 2016, SHE WENT INTO PRETERM LABOR (34 WEEKS) AND HER BABY WAS BORN WITH MULTIPLE BIRTH DEFECTS. CUSTOMER INDICATED THAT HER DAUGHTER IS NOW 3 YEARS OLD AND HAS PICA. CUSTOMER STATED THAT SHE USED TEST STRIPS DURING HER PREGNANCY AND WAS CONCERNED THAT THE TEST STRIPS THAT SHE WAS USING DURING HER PREGNANCY IN 2016 WERE RECALLED. CUSTOMER STATED THAT SHE READ THE RECALL LETTER AND IT INDICATED THAT THE METER GAVE LOWER RESULTS. CUSTOMER STATED THAT HER GLUCOSE LEVEL WAS HIGHER DURING PREGNANCY. CUSTOMER BELIEVES THAT HER PREGNANCY WAS AFFECTED BECAUSE SHE BELIEVES THE STRIPS WERE PART OF THE RECALL. CUSTOMER DID NOT PROVIDE ANY IDENTIFYING INFORMATION REGARDING THE SPECIFIC PRODUCTS ALLEGEDLY USED IN 2016. CUSTOMER DID NOT REPORT THAT SHE WAS CURRENTLY EXPERIENCING ANY SYMPTOMS OR REQUIRED ANY MEDICAL ATTENTION DURING THE (B)(6) 2019 CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445327 TRUERESULT BLOOD GLUCOSE SYSTEM NBW TRIVIDIA HEALTH, INC. TRUERESULT N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR SECOND THERAPY| SECOND THERAPY