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

Catalog Number 05942861018

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

The test strips were requested for investigation.Replacement product was sent.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.

Event Description

We received an allegation of a questionable glucose result for one patient tested with an accu-chek inform ii meter serial number (b)(4) compared to a different accu-chek inform ii meter serial number (b)(4) and an unknown blood gas machine.The patient's glucose result with accu-chek inform ii meter serial number (b)(4) was 2.8 mmol/l."within minutes," the patient's glucose result with accu-chek inform ii meter serial number (b)(4) was 4.2 mmol/l.The patient's glucose result with the blood gas machine was "4.?" mmol/l.The specific result was requested but not provided by the customer.

Manufacturer Narrative

The reporter's meter was provided for investigation where it was tested with retention test strips and controls.Control ranges (in mg/dl): level 1: 100 - 136.Level 2: 261 - 353.Measurement results (in mg/dl) on returned device: level 1: 113, 115, 114.Level 2: 296, 290, 296.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: 13110025
• MDR Text Key: 290458534
• Report Number: 1823260-2021-03908
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 05942861018
• Device Lot Number: 479603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2022
• 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
• Patient Age: 24 MO