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 09/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer received a questionable low glucose result for one patient from accu-chek inform ii serial (b)(4).The initial result at 5:49 am was "rr lo" and was transferred as 37 mg/dl.They repeated testing on same patient as he did not appear to be symptomatic of low blood glucose.At 5:53 am, the result was 77 mg/dl.The patient was not treated based on the initial result.They gave the patient orange juice based on the result of 77 mg/dl.There was no allegation of an adverse event.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.

Manufacturer Narrative

The customer's strips were received for investigation and were tested with a retention meter and control material.Control ranges: level 1 30-60 mg/dl, level 2 261-353 mg/dl.Results: level 1 ¿ 45, 45, 45 mg/dl, level 2 ¿ 298, 303, 298 mg/dl.All returned results are within acceptable range.No information was provided in the complaint case that would point to a cause for the result discrepancy.None of the given treatments/medications are currently known to interfere with the accuracy of the test results.Potential causes for the issue include traces of food on the fingers or fatty residues from skin cream products, residues of water or disinfectant on the skin, or peripheral circulation impairment.

• 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: 6941655
• MDR Text Key: 90336162
• Report Number: 1823260-2017-02277
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/07/2017

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: Nurse
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 05942861001
• Device Lot Number: 475484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2017
• Initial Date FDA Received: 10/11/2017
• Supplement Dates Manufacturer Received: 09/26/2017
• Supplement Dates FDA Received: 11/07/2017
• 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