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 01/23/2024

Event Type  malfunction  

Manufacturer Narrative

The accu-chek inform ii meter (meter 1) serial number was (b)(6).The accu-chek inform ii meter (meter 2) serial number was (b)(6).The accu-chek inform ii meter (meter 3) serial number was (b)(6).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.

Event Description

We received an allegation of questionable glucose results for 1 patient tested with an accu-chek inform ii meter (meter 1) when compared to an unknown laboratory method and to a 2nd accu-chek inform ii meter (meter 2).On (b)(6) 2023: at 3:01 am the initial result was 126 mg/dl (meter 1).At 4:57 am the meter result was 121 mg/dl (meter 1).At 5:10 am the laboratory result was 134 mg/dl.At 6:13 am the meter result was 85 mg/dl (meter 1).At 6:13 am the laboratory result was 145 mg/dl.At 7:26 am the meter result was 236 mg/dl (meter 2).At 7:47 am the patient was given 4 units of humalog insulin based on this result.No serious injury occurred as a result of the treatment.At 8:37 am the laboratory result was 450 mg/dl.At 9:38 am the patient was given 12 units of humalog insulin based on this result.No serious injury occurred as a result of the treatment.At 10:30 am the meter result was 381 mg/dl (meter 2).At 11:18 am the patient was given 12 units of humalog insulin based on this result.No serious injury occurred as a result of the treatment.At 3:13 pm the meter result was 322 mg/dl (meter 1).At 4:02 pm the patient was given 10 units of humalog insulin based on this result.No serious injury occurred as a result of the treatment.At 4:28 pm the laboratory result was 511 mg/dl.At 8:23 pm the laboratory result was 263 mg/dl.At 8:27 pm the meter result was 193 mg/dl (meter 2).At 8:27 pm the meter result was 248 mg/dl (meter 1).At 8:30 pm the meter result was 246 mg/dl (meter 3).At 8:43 pm the patient was given 10 units of humalog insulin based on this result.No serious injury occurred as a result of the treatment.On (b)(6) 2024: at 12:30 am the laboratory result was 514 mg/dl.At 12:32 am the meter result was 464 mg/dl (meter 1).At 3:25 am the meter result was 174 mg/dl (meter 1).The qcs were performed and the results obtained were: meter 1: on (b)(6) 2024 at 4:42 pm, the qc was out of range while at 4:53 - 4:54 pm, the qc was in range.On (b)(6) 2024 at 4:55 - 4:56 pm, the qc was in range.Meter 2: on (b)(6) 2024 at 4:40 - 4:41 pm, the qc was in range.On (b)(6) 2024 at 8:04 - 8:05 pm, the qc was in range.

• 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: 18730104
• MDR Text Key: 336747333
• Report Number: 1823260-2024-00468
• Device Sequence Number: 1
• Product Code: LFR
• 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: 02/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• 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: 01/25/2024
• 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
• Treatment: ALBUTEROL; HUMALOG; LANTUS; LIPITOR; TYLENOL
• Patient Sex: Female