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

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.".

• Brand Name: ACCU-CHEK ® INFORM II TEST STRIPS
• Type of Device: BLOOD 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 Key: 6767309
• MDR Text Key: 81825294
• Report Number: 1823260-2017-01598
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121679
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 05942861001
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2017
• Initial Date FDA Received: 08/04/2017
• 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: N
• Patient Sequence Number: 1
• Treatment: ASCORBIC ACID
• Patient Outcome(s): Death