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 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).The test strips are no longer available to return.

Event Description

The customer complained of discrepant glucose results for 1 patient tested on two accu-chek inform ii meters with serial numbers (b)(4) (meter a) and (b)(4) (meter b).The patient was brought to the emergency room by the emergency medical technicians and was diagnosed with hypoglycemia at 7:00 p.M.The result from meter a was 32 mg/dl.The patient was retested on meter a at 7:19 p.M.And 7:20 p.M.With results of 15 mg/dl and 14 mg/dl respectively.The patient was treated with dextrose between 7:09 p.M.And 7:18 p.M.At 7:24 p.M.The patient was tested on meter b and the result was 90 mg/dl.The glucose result from the laboratory at 7:45 p.M.Was 184 mg/dl.At 10:10 p.M.The patient was tested on meter b and the result was 26 mg/dl.At 10:13 p.M.The patient was tested on meter a and the result was 47 mg/dl.At 11:00 p.M.The patient was tested on meter a and the result was 90 mg/dl.At 11:16 p.M.The patient was retested on meter a and the result was 56 mg/dl.On 03-feb-2018 at 12:01 a.M.The patient was tested on meter a and the result was 27 mg/dl.At 12:03 a.M.The patient was tested on meter b and the result was 29 mg/dl.The same strip lot was used on both meters but it is not known if the same strip vial was used on both meters.There was no allegation that an adverse event occurred due to the device.Er staff believed the low results based on the diagnosis of hypoglycemia by the emts and continued to test the patient on both meters.They followed protocol by treating the patient with dextrose based on the low results.Their protocol does not instruct them to use a second meter.They are to repeat the test on the same device or perform a laboratory test if results are questioned.The patient continued to have erratic results in the hospital but has since been released.The customer was unable to provide any additional details about the patient.The meter and test strips were requested for investigation, however the test strips that were in use at the time of the event are no longer available.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.The customer returned the meter and a strip vial with the same lot used at the time of the event.Qc tests were performed on the returned product with the following results: qc ranges: level 1: 30-60 mg/dl, level 2: 261-353 mg/dl.Results received: level 1 ¿ 45 mg/dl, 46 mg/dl, 45 mg/dl, level 2 ¿ 319 mg/dl, 316 mg/dl, 310 mg/dl.All returned results were within the acceptable range.The patient had hypoglycemia which affects peripheral circulation.This is addressed in product labeling.The investigation was unable to find a definitive root cause for this event.

• 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: 7341683
• MDR Text Key: 103155971
• Report Number: 1823260-2018-00846
• 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: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 05942861001
• Device Lot Number: 476125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2018
• 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: 98 YR