BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 3223697 · Received July 12, 2013

    Report

    Report Number
    3008382007-2013-19587
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    July 9, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K062195
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP 4: SUPPLEMENTAL REPORT (11/5/2013)- (B)(4).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP 2: SUPPLEMENTAL REPORT (09/19/2013).

    Additional Manufacturer Narrative · 1

    FOLLOW-UP 1: SUPPLEMENTAL REPORT (07/18/2013), PT AGE: (B)(6) 1918. MEDICAL RECORDS PROVIDED TO LFS WERE REVIEWED BY A MEDICAL DOCTOR ON (B)(6) 2013. THE RECORDS INCLUDED NURSING NOTES, ADMISSION NOTES, EMS NOTES, LABORATORY RESULT REPORTS, RADIOLOGY REPORTS, PATHOLOGY REPORTS, AND THE CORONER¿S REPORT ALL FROM 2011 AS WELL AS A FEW RECORDS FROM 1997 RELATED TO A RECTAL CARCINOMA. RECORDS PERTAINING TO THE REPORTED HYPOGLYCEMIA ON (B)(6) 2010 COULD NOT BE FOUND. IN (B)(6) 2011, THE PATIENT REQUIRED TREATMENT FOR AN INFECTION, WHICH LATER WAS DETERMINED TO BE (B)(6) FOUND IN BLOOD CULTURES. OTHER RECENT ISSUES NOTED INCLUDED BED SORES IN THE SACRAL AREA AND A BURN ON THE LEFT ARM CAUSED BY A HEAT COMPRESS. THE PATIENT HAD A PICC (CENTRAL IV) LINE PLACED ON (B)(6) 2011 AND RETURNED TO THE NURSING FACILITY. ON (B)(6) 2011, EMS WAS CALLED AS THE PATIENT HAD SHORTNESS OF BREATH AND FEVER. UPON ARRIVAL OF EMS, THE PATIENT LOST HIS PULSE AND PASSED AWAY. IT WAS NOTED, THE PATIENT HAD MULTIPLE MEDICAL PROBLEMS INCLUDING ALZHEIMERS DISEASE, CORONARY ARTERY DISEASE, SEIZURE, STROKE, DIABETES, HYPERTENSION, ATRIAL FIBRILLATION, ENCEPHALOPATHY (ANOXIC BRAIN INJURY), SPASMS, AND DYSPHAGIA. THE PATIENT LIVED IN A (B)(6) NURSING HOME. PRIOR TO THIS EVENT, THE PATIENT HAD MULTIPLE ADMISSIONS TO THE HOSPITAL DURING 2011 RELATED TO SEIZURES, DILANTIN TOXICITY, AND URINARY TRACT INFECTION. THE CORONER¿S ¿PROVISIONAL DIAGNOSES¿ AFTER EXAMINATION OF THE PATIENT¿S BODY INCLUDED ATHEROSCLEROTIC, HYPERTENSIVE CARDIOVASCULAR DISEASE AND BILATERAL PULMONARY THROMBOEMBOLI. THE FINAL REPORT WAS NOT AVAILABLE. BASED ON THE ABOVE INFORMATION, THE MEDICAL DOCTOR WHO REVIEWED THE PROVIDED RECORDS, COULD NOT FIND A LINK BETWEEN THE REPORTED HYPOGLYCEMIC EVENT IN (B)(6) 2010 AND THE PATIENT¿S DEATH IN (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE MORNING OF (B)(6) 2010, THE LAY USER/PATIENT CHECKED HIS BLOOD GLUCOSE SEVERAL TIMES WITH A ONETOUCH ULTRA METER AND OBTAINED RESULTS IN THE ¿400¿S MG/DL¿ RANGE. IT IS NOT KNOWN WHAT THE PATIENTS NORMAL/TYPICAL READINGS ARE AT THAT TIME OF THE DAY. PER THE DOCUMENTATION, THE PATIENT REPORTEDLY TOOK AN ¿OVERDOSE OF INSULIN AND DIABETIC MEDICATION¿ (TYPE AND AMOUNT NOT PROVIDED) IN RESPONSE TO THE ELEVATED RESULTS OBTAINED WITH THE SUBJECT METER. AT AN UNSPECIFIED TIME, LATER THAT SAME DAY, THE PATIENT REPORTEDLY WENT INTO A ¿DIABETIC COMA¿. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE PATIENT¿S ALLEGED SEVERE BLOOD GLUCOSE EXCURSION. IT IS NOT KNOWN WHAT THE PATIENT¿S BLOOD GLUCOSE LEVELS WERE WHEN TESTED ON ANOTHER DEVICE AT THE TIME OF THE INJURY. IT IS ALSO NOT KNOWN WHAT TREATMENT THE PATIENT RECEIVED WHEN HE WENT INTO THE ¿DIABETIC COMA¿. IT WAS ALSO REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2011, APPROXIMATELY 1 YEAR LATER. THE CAUSE OF DEATH IS UNKNOWN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY OBTAINED INACCURATE HIGH READINGS WITH THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULTS, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN. HOWEVER, BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT A PRODUCT ISSUE WITH A LFS METER CAUSED AND/OR CONTRIBUTED TO THE PATIENT¿S DEATH. LIFESCAN IS IN THE PROCESS OF RECEIVING MEDICAL FILES RELATED TO THIS COMPLAINT AND WILL SUBMIT FURTHER INFORMATION IN A SUPPLEMENTAL REPORT ONCE ALL THE RECORDS ARE RECEIVED AND REVIEWED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322914 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R