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 03/24/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number for meter a is (b)(6).The serial number for meter b is (b)(6).The product was returned 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 investigation is ongoing.

Event Description

There was an allegation of questionable glucose results from 2 accu-chek inform ii meters compared to laboratory results using an unknown method.The result from meter a (uu14478370) was 62 mg/dl at 15:46.The laboratory result was 117 mg/dl at 15:45.The result from the patient's dexcom device was 121 mg/dl at 15:45.The result from meter a uu14478370 was 133 mg/dl at 18:15.The result from meter b uu14508915 was 159 mg/dl at 18:15.The result from the patient's dexcom device was 251 mg/dl at 18:15.The result from the patient's "personal meter" was 212 mg/dl at 18:15.The type of meter was not provided.The laboratory result was 270 mg/dl at 18:33.The result from meter a (uu14478370) was 190 mg/dl at 18:42.The result from the patient's dexcom device was 250 mg/dl at 18:42.

Manufacturer Narrative

Testing was performed with the returned test strips using glycolyzed blood.All results were acceptable.All testing with the returned strips produced acceptable results and no strip defects were observed.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: 19127081
• MDR Text Key: 341254208
• Report Number: 1823260-2024-01192
• 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: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2024
• 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: 671033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male