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 Known Impact Or Consequence To Patient (2692)

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that they received an erroneous result for one patient tested with accu-chek inform ii meter serial number (b)(4).The meter also had an error.The meter was reset and the error cleared.The test strip port of the meter was contaminated.At 12:10 a.M., a heelstick sample from the patient was tested on the meter and the result was 29 mg/dl.At 12:17 a.M., another sample from the patient was tested on a second accu-chek inform ii meter (serial number (b)(4)) and the result was 41 mg/dl.The 41 mg/dl value was believed to be correct and the decision was made to not treat the patient based on this value.No adverse events were alleged to have occurred with the patient.The normal glucose range used at the facility for neonates is 50 - 80 mg/dl.A critical low value is 40 mg/dl.The patient has had no changes in vitamins.The patient was breast fed and also had some formula.There were no changes in the patients food or drink consumed prior to the event.Controls are run daily on the meter and have to pass.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.Both customer meters, test strips, and controls were returned by the customer for investigation.The customer meters, test strips, and controls were tested using a retention battery.Control ranges: level 1: 30 - 60 mg/dl.Level 2: 261 - 353 mg/dl.Results uu14032686: glucose contamination was observed in the test strip port.Level 1: 43 mg/dl, 45 mg/dl, 44 mg/dl.Level 2: 304 mg/dl, 304 mg/dl, 308 mg/dl.Results uu14163592: level 1: 44 mg/dl, 45 mg/dl, 45 mg/dl.Level 2: 307 mg/dl, 309 mg/dl, 310 mg/dl.All results were within acceptable range.The observed contamination on the meter could be a reason for the result discrepancy.

• 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: 6940156
• MDR Text Key: 90311929
• Report Number: 1823260-2017-02265
• 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
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 05942861001
• Device Lot Number: 475490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2017
• Initial Date FDA Received: 10/11/2017
• 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
• Patient Age: 1 DA
• Patient Weight: 4