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

Catalog Number 05942861001

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2020

Event Type  malfunction  

Manufacturer Narrative

The meter and test strips were requested for investigation.The product has not been received at this time.If the product is returned in the future, a follow up report will be submitted routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received questionable glucose results from (meter a) accu-chek inform ii meter serial number (b)(4) compared to (meter b) accu-chek inform ii meter serial number (b)(4).At 21:53 the result taken with meter a was 260mg/dl.The operator of the meter did not believe this result was correct.At 21:57 the result taken with meter b was 45mg/dl.At 21:58 the result taken with meter b was 49mg/dl.Controls on meter (b)(4) were run on (b)(6) 2020 at 5:48am and (b)(6) 2020 at 4:55am.Both level 1 and level 2 controls passed.Controls on meter (b)(4) were run on (b)(6) 2020 at 5:48am and (b)(6) 2020 at 11:00am.Both level 1 and level 2 controls passed.

• 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: 9781391
• MDR Text Key: 219398927
• Report Number: 1823260-2020-00616
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 05942861001
• Device Lot Number: 478330
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2020
• 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: 73 YR
• Patient Weight: 57