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 12/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that they received erroneous results when testing one patient with two accu-chek inform ii meters (serial numbers(b)(4)).At 6:00 a.M., a sample was collected from the patient and tested with a laboratory method, resulting as 154 mg/dl.At 7:44 a.M., a sample from the patient was tested on meter serial number (b)(4), resulting as 511 mg/dl.At 7:46 a.M., a sample from the patient was tested on accu-chek inform ii meter serial number (b)(4), resulting as 201 mg/dl.At 7:46 a.M., a sample from the patient was tested on meter serial number (b)(4), resulting as 145 mg/dl.The customer also noted that they received a system error on this meter on (b)(6) 2018.The customer believed the 201 mg/dl value from meter serial number (b)(4) to be correct.No adverse events were alleged to have occurred with the patient.The patient was not seriously injured.Quality controls were tested on the meters within 24 hours and these passed.The customer's product was requested for investigation and replacement product was sent to the customer.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.

Manufacturer Narrative

The customer stated that in her experience, the patient was not showing signs or symptoms of hyperglycemia.The customer did not believe that there was any edema at the site of sample collection.The customer did not have any remaining test strips.

• 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: 7203288
• MDR Text Key: 98169954
• Report Number: 1823260-2018-00167
• Device Sequence Number: 1
• Product Code: LFR
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2018
• 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: 475795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2018
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1