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 Consequences Or Impact To Patient (2199)

Event Date 05/09/2018

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)#: (b)(4).

Event Description

The customer received a questionable glucose result for 1 patient from an accu-chek inform ii meter with serial number (b)(4).At 17:04 the glucose result was 455 mg/dl.At 17:11 the glucose result was 310 mg/dl.There was no allegation of an adverse event.The patient was discharged from the hospital.The customer confirmed that qc was performed and was acceptable.The device was requested for investigation and a replacement was sent.Routine retention testing is performed.Retention testing data is reviewed and appropriate actions are taken as needed.Retention material complies with specification.

Manufacturer Narrative

The customer did not return any materials for investigation.The investigation was unable to find a definitive root cause.

• 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
• MDR Report Key: 7542525
• MDR Text Key: 109636884
• Report Number: 1823260-2018-01592
• Device Sequence Number: 1
• Product Code: LFR
• Combination Product (y/n): N
• PMA/PMN Number: K121679
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• 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: 476575
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR