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

Catalog Number 05942861001

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 09/26/2023

Event Type  malfunction  

Event Description

We received an allegation of questionable glucose results from two accu-chek inform ii meters: meter a with serial number: (b)(6).Meter b with serial number: (b)(6).The result from meter a at 11:24 a.M.Was 129 mg/dl.The result from meter a at 11:26 a.M.Was 136 mg/dl.At the same time as the meter results, the patient's dexcom g6 continuous monitoring system read 65 mg/dl.The patient was treated with an unspecified dose of 50% dextrose based on this reading.The result from meter b at 11:45 a.M.Was 146 mg/dl.This reading was believed to be the most accurate.The result from meter a at 11:46 a.M.Was 263 mg/dl.The reporter stated that the patient must have been treated with dextrose 50%, as the notes state that after treatment the patient's meter result (from an unspecified meter) was 103 mg/dl.It is not clear if this note was referring to the earlier treatment with 50% dextrose at the time of the first comparison approximately 15-20 minutes earlier.The laboratory result at 1:34 p.M.Was 188 mg/dl.

Manufacturer Narrative

The test strips have been requested for investigation but have 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 test 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 returned test strips were tested using a retention meter and quality controls.Control ranges: level 1: 30-60 mg/dl level 2: 261-353 mg/dl results: level 1: 45, 45, 45 mg/dl level 2: 301, 305, 299 mg/dl all returned results are within acceptable range.No information was provided in the complaint case that would point to a cause for the result discrepancy.Medwatch field d9 was updated.

• 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: 18015186
• MDR Text Key: 326687099
• Report Number: 1823260-2023-03438
• 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,Followup
• Report Date: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• 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: 670236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• 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
• Treatment: APRESOLINE; CEFOTAN; CELEBREX; CHANTIX; FLAGYL; FLOMAX; LANTUS; LIPITOR; LOPRESSOR; LOVENOX; LYRICA; NORVASC; ROBAXIN; ROXICODONE; SYNTHROID; ULTRAM; VIBROMYCIN; VOLTAREN; ZOFRAN
• Patient Age: 75 YR
• Patient Sex: Male