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

Catalog Number 05942861001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/25/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).The device was requested for investigation, but will not be returned.

Event Description

The customer initially inquired about what the approved sample types were when using an accu-chek inform ii meter.The customer stated that one of their operators were taking samples from a patient's earlobe, which is not an approved use, and comparing them to results from a fingertip.The customer stated that they had some questionable results for 1 patient that was tested with multiple accu-chek inform ii meters.The customer stated there were questioning the results from the accu-chek inform ii meter with a serial number of (b)(4).The patient was administered to the intensive care unit (icu) from the emergency room (er) with acute renal failure and hypoglycemia.Please refer to the attachment to this medwatch for patient data.The erroneous results were reported outside of the laboratory.The patient's current condition is okay and is currently in the icu.Use of the accu-check inform ii has not been evaluated in the critically ill.There was no adverse event.The customer did not know what the patient's normal glucose range was.The customer did not have any of the patient's health history.The customer did no know the patient's medication history, if there have been any changes in the patient's medications, diet, or exercise, or if the patient had any other medical devices.The customer stated that the patient's sample collection sites were cleaned with alcohol and were wiped dry.The customer runs control testing on the accu-chek inform ii meters every 24 hours.The suspected product was requested for investigation, but the customer stated that all vials of strips from the event have been used and are not available for return.Further investigation stated that the patient's condition of hypoglycemia is known to affect peripheral blood flow.Product labeling states " if peripheral circulation is impaired, collection of capillary blood from the approved sample sites is not advised as the results might not be a true reflection of the physiological blood glucose level." routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.The investigation was unable to find a definitive root cause as no product was available to be returned for further investigation.

• 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: 7403614
• MDR Text Key: 105264758
• Report Number: 1823260-2018-01091
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 05942861001
• Device Lot Number: 475495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2018
• 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
• Patient Age: 82 YR