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

Catalog Number 05942861164

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2020

Event Type  malfunction  

Manufacturer Narrative

The customer's meter and test strips were requested for investigation.The test strips are not expected to be returned.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.This event occurred in (b)(6).

Event Description

The initial reporter received questionable glucose results from an inform ii meter with serial number (b)(4) (meter a) when compared to an inform ii meter with serial number (b)(4) (meter b).Quality controls (qc) were run on meter a the day before the event ((b)(6) 2020) at 10:46 am.Both levels of control passed: level 1: 2.4 mmol/l (range: 2.1-2.7 mmol/l), level 2: 16.7 mmol/l (range: 15.7-17.9 mmol/l).The result from meter a was 14.1 mmol/l at 2:48 am.The result from meter b was 3.3 mmol/l at 2:52 am.The same person performed both tests.The result from meter b was believed to be correct.Qc was then run on meter a with failing results: level 1 results (range: 2.1-2.7 mmol/l): at 2:56 am the result was 2.8 mmol/l (fail).At 2:57 am the result was 3.1 mmol/l (fail).Level 2 result (range: 15.7-17.9 mmol/l): at 2:57 am the result was 16.1 mmol/l (pass).The initial reporter stated there was a "blue residue" was in the strip port of meter a.It is unknown if the meter was contaminated before or after the event.

• Brand Name: ACCU-CHEK ® PERFORMA 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: 10000033
• MDR Text Key: 222555296
• Report Number: 1823260-2020-01110
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K043474
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05942861164
• Device Lot Number: 477424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2020
• 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