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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ACCU-CHEK ® INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS

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ROCHE DIAGNOSTICS ACCU-CHEK ® INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS Back to Search Results
Catalog Number 05942861001
Device Problem High Test Results (2457)
Patient Problem Death (1802)
Event Date 04/03/2017
Event Type  Death  
Manufacturer Narrative

(b)(4).

 
Event Description

A roche representative stated the customer received a questionable high glucose result for one patient from an accu-chek inform ii meter. The serial number was requested but was not provided. The specific date of the event was requested, but was not provided. The patient was receiving a high dose of ascorbic acid and the hospital had a policy to not use the device on patients receiving this treatment. However, the staff member did not follow the policy and the glucose result from the meter was greater than 400 mg/dl. The patient was given a dose of insulin based on the result. Additional information was provided that the patient later died. The exact date and cause of death was requested but was not provided. The hospital stated the death was due to a human error by the nurse caring for the patient. A comparison test was performed with a blood gas instrument, but no specific details could be provided. Multiple attempts to obtain further information regarding the event were made via several forms of communication. No additional information was provided. The customer was advised of the limitations for use of the strips on patients receiving ascorbic acid. The suspect meter and strips were requested to be returned for further investigation, but no product was received. Therefore a specific root cause could not be determined. Routine retention testing is performed. Retention testing data is reviewed and appropriate actions are taken as needed. Potential factors that could influence the results include the intravenous administration of ascorbic acid, impairment of peripheral circulation, and incorrect storage of the strips. A malfunction of the device was not indicated. Product labeling states, "intravenous administration of ascorbic acid which results in blood concentrations of ascorbic acid >3 mg/dl will cause overestimation of blood glucose results. ".

 
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Brand NameACCU-CHEK ® INFORM II TEST STRIPS
Type of DeviceBLOOD GLUCOSE MONITORING TEST STRIPS
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM 68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key6767309
MDR Text Key81825294
Report Number1823260-2017-01598
Device Sequence Number1
Product Code LFR
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK121679
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 08/04/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/04/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number05942861001
Device LOT NumberASKU
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/04/2017 Patient Sequence Number: 1
Treatment
ASCORBIC ACID
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