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

Catalog Number 05942861164

Device Problems High Test Results (2457); Output Problem (3005); Non Reproducible Results (4029)

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

Event Date 10/30/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable results from two accuchek inform ii meters, serial numbers (b)(6), compared to a laboratory result.At 4:48 p.M., meter (b)(6) gave a result of 23.6 mmol/l.At 4:55 p.M., meter (b)(6) gave a result of 19.3 mmol/l.At 4:58 p.M., meter (b)(6) gave a result of 12 mmol/l.The user washed their hands prior to testing.At 5:10 p.M., meter (b)(6) gave a result of 10.3 mmol/l.At 5:19 p.M., a venous sample was collected and the laboratory result was 8.2 mmol/l.At 7:51 p.M., meter (b)(6) gave a result of 7.7 mmol/l.

Manufacturer Narrative

Bother meters were requested for investigation.No product has not been received at this time.If the product is returned in the future, a follow up report will be submitted.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.

Manufacturer Narrative

The customer provided information stating that it was determined that accu-chek serial number (b)(6) glucometer was not in error and the cause of the event was due to pre-analytical issues at their site.The meter was put back into use at the customer site.The investigation did not identify a product problem.

• Brand Name: ACCU-CHEK INFORM II
• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18268837
• MDR Text Key: 329745988
• Report Number: 1823260-2023-03869
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K043474
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• 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: 670365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1