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 11/09/2023

Event Type  malfunction  

Event Description

We received an allegation of questionable glucose results for 1 patient tested with accu-chek inform ii meter with serial number (b)(6) (meter a) when compared with another accu-chek inform ii meter with serial number (b)(6) (meter b) and the laboratory.The result from meter a at 5:18 am was 217 mg/dl.The result from meter a at 11:16 am was 470 mg/dl.The reporter believed this result to be inaccurately high for the patient.The laboratory result at 11:16 am was 222 mg/dl.They believed this result to be accurate.The result from meter a at 3:28 pm was 398 mg/dl.They believed this result to be inaccurate.The result from meter b at 3:35 pm was 204 mg/dl.They believed this result to be accurate.The result from meter b at 9:03 pm was 252 mg/dl.They believed this result to be accurate.

Manufacturer Narrative

The quality controls passed on both meters within 24 hours of the event.The reporter's test strips were requested for investigation.The test strips have not been received at this time.If they are returned in the future, a follow-up report will be submitted.The meter with serial number (b)(6) was received for investigation and was tested with retention test strips and controls.Investigation results (in mg/dl): level 1 ¿ 43, 42, 43 (control range: 30-60).Level 2 ¿ 299, 296, 298 (control range: 261-353).All results are within acceptable range.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.

• 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: 18309597
• MDR Text Key: 330229931
• Report Number: 1823260-2023-03945
• 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: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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: 670217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• 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