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 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that they received an erroneous result for one neonate patient tested with accu-chek inform ii meter serial number (b)(4).At 11:29 a.M., a capillary heel stick sample from the patient was tested, resulting as 29 mg/dl.At 11:48 a.M., a capillary heel stick sample from the patient was tested, resulting as 24 mg/dl.At 12:48 a.M., a capillary heel stick sample from the patient was tested, resulting as 22 mg/dl.Within 10 minutes of the meter test, a venous sample was collected from the patient and tested with a laboratory method, resulting as 56 mg/dl.The nursing staff believed that the 56 mg/dl result was more accurate.The patient was treated with sugar water at an unknown time based on the meter result of 22 mg/dl.No adverse events were alleged to have occurred with the patient as a result of being treated.The patient is in normal condition.The same vial of test strips was used for all meter testing.Quality controls were run on the meter within 24 hours of testing 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's meter was returned for investigation.The returned meter was measured with retention strips.Control ranges: level 1 30-60 mg/dl, level 2 261-353 mg/dl.Results: level 1 ¿ 43, 45, 45 mg/dl, level 2 ¿ 298, 303, 299 mg/dl.All returned results are within acceptable range.

Manufacturer Narrative

The customer's product was not returned for investigation, so no further investigation was possible.There was no information provided related to the neonate patient's stress, blood flow to the site, tube/technique used by the laboratory or nurse, or condition of the patient at the time of the comparison.All of these factors may have affected the accuracy of the obtained results.None of the treatments provided to the patient are known to interfere with the accuracy of the test results.

• 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: 7128183
• MDR Text Key: 96026332
• Report Number: 1823260-2017-02988
• 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,Followup
• Report Date: 12/05/2018

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: 11/30/2018
• Device Catalogue Number: 05942861001
• Device Lot Number: 475910
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/19/2017
• Supplement Dates Manufacturer Received: 12/06/2017; 12/06/2017
• Supplement Dates FDA Received: 01/23/2018; 12/05/2018
• 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