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

Catalog Number 05942861001

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that they received erroneous results when testing one patient with accu-chek inform ii meter serial number (b)(4).At 5 a.M.On (b)(6) 2018, the patient had a sample collected for laboratory testing and it resulted with a glucose value of 99 mg/dl.At 7:00 a.M.On (b)(6) 2018, a sample collected from the patient was tested on the meter and the glucose result was 233 mg/dl.At 7:03 a.M.On (b)(6) 2018, a sample collected from the patient was tested on the meter and the glucose result was 129 mg/dl.No adverse events were alleged to have occurred with the patient.The patient was not treated based on the meter results.The customer stated that samples were collected by fingerstick, but could not confirm how the meter testing was performed.The customer saw some blue solution on the meter, but stated he cleaned this off and felt it was just on the outside of the meter.Quality controls were tested on the meter with a new vial of test strips and controls passed.There was no delay in the patient's normal routine.The patient's food and beverage were normal, there were no changes in food or drink consumed.The customer's test strips were requested for investigation.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.

Manufacturer Narrative

The customer did not return any materials for investigation.Without these materials to investigate, a specific root cause could not be determined.

• 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
• MDR Report Key: 7345954
• MDR Text Key: 103162809
• Report Number: 1823260-2018-00870
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• PMA/PMN Number: K121679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 05942861001
• Device Lot Number: 476121
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: METFORMIN; MULTIVITAMIN; VITAMIN D
• Patient Age: 81 YR