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

Catalog Number 05942861003

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2021

Event Type  malfunction  

Event Description

The initial reporter received questionable glucose results with accu-chek inform ii meters (b)(4).Patient 1 the result from meter (b)(4) was 33 mg/dl.The result from another device was 160 mg/dl.Patient 2 the result from meter (b)(4) was 38 mg/dl.The result from another device was 203 mg/dl.The measurements were taken within 10 minutes of each other.The quality controls were acceptable.

Manufacturer Narrative

The meters and test strips were requested for investigation.On a regular basis, accu-chek inform strips of lots currently valid in the market are tested as part of routine retention testing and results have passed the internal inspection.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.

Manufacturer Narrative

The customer¿s meter was returned where it was tested using retention test strips and retention controls.Control ranges: level 1 30-60 mg/dl, level 2 261-353 mg/dl.Results: level 1 ¿ 45, 44, 45 mg/dl.Level 2 ¿299, 311, 296 mg/dl.All returned results are within the acceptable range.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 12977701
• MDR Text Key: 284835604
• Report Number: 1823260-2021-03654
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K121679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 05942861003
• Device Lot Number: 479298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2021
• 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
• Patient Sequence Number: 1