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

Catalog Number 05942861001

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/20/2021

Event Type  malfunction  

Event Description

There was a complaint of questionable glucose results for one patient tested with accu-chek inform ii meter serial number (b)(4) (meter a) compared to a second accu-chek inform ii meter serial number (b)(4) (meter b).The result from meter a at 9:18 pm was 374 mg/dl.The initial result was not consistent with the patient¿s previous results and a repeat was performed using meter b.The result from meter b at 9:22 pm was 146 mg/dl.The patient did not require medical treatment.

Manufacturer Narrative

The customer ran control tests within 24 hours of the meter test.They met the acceptance criteria.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.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13205664
• MDR Text Key: 288658786
• Report Number: 1823260-2022-00080
• Device Sequence Number: 1
• Product Code: LFR
• UDI-Device Identifier: 00365702428102
• UDI-Public: 00365702428102
• Combination Product (y/n): N
• 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: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 05942861001
• Device Lot Number: 479338
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2021
• 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: ACETAMINOPHEN; ATORVASTATIN; BISACODYL; CALCIUM PLUS VITAMIN D; DEXTROSE 50%; ENOXAPARIN; ESCITALOPRAM; FLUCONAZOLE; FOLIC ACID; FUROSEMIDE; HYDROXYCHLOROQUINE; INSULIN ASPART; IPRATROPIUM NASAL SPRAY; LEVOTHYROXINE; MAGNESIUM HYDROXIDE; MELATONIN; NEBIVOLOL; PANTOPRAZOLE; PREDNISONE; SENNA TAB; SODIUM CHLORIDE
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 56 KG