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

Catalog Number 05942861001

Device Problem Low Test Results (2458)

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

Event Date 02/27/2024

Event Type  malfunction  

Event Description

We received an allegation of a questionable glucose result for one patient tested with the accu-chek inform ii meter.The meter result at 9:46 pm was 10 mg/dl.This result did not match the condition of the patient.The reporter stated that the normal glucose range for their facility is 70 mg/dl to 140 mg/dl.Within 15 minutes of the meter test, a laboratory test was performed using peripheral blood, and another meter test was also performed using a second accu-chek inform ii meter.The result from the second accu-chek inform ii meter matched the laboratory result.

Manufacturer Narrative

The serial number of the customer's accu-chek inform ii meter is (b)(6).The customer stated that the qcs passed on the date of event.The customer stated there was qc contamination in the test strip port of the meter.The test strips were requested for investigation.The 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 meter was received for investigation.The investigation found contamination within the meter's test strip port.Further investigation was not possible.Product labeling states: "when applying the control solution, position the meter so that the test strip port is always higher or on the same level as the control solution.This prevents any excess solution from flowing down the strip and entering the meter." "when applying the sample, position the meter so that the test strip port is always higher or on the same level as the blood drop.This prevents any excess blood from flowing down the strip and entering the meter." "maintenance and care cleaning/disinfecting the meter clean the meter to remove visible soil and organic material for safe handling and/or prior to disinfecting.Warning avoid getting liquid into the test strip port! moisture in the strip port may lead to incorrect blood glucose results." the investigation determined the event was consistent with customer mishandling.The investigation did not identify a product problem.

• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18948327
• MDR Text Key: 338447072
• Report Number: 1823260-2024-00841
• Device Sequence Number: 1
• Product Code: LFR
• UDI-Device Identifier: 00365702428102
• UDI-Public: 00365702428102
• Combination Product (y/n): Y
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05942861001
• Device Lot Number: 670856
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• 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 Sex: Male