MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C513 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C513

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/22/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer stated that they received an erroneous result for one patient sample tested for a1c-3 tina-quant hemoglobin a1c gen.3 (hba1c) on a cobas c513 analyzer commercial system (c513).The customer repeated approximately 13 other samples tested at the same time and all repeat results matched original results.The sample initially resulted as 8.55 % and this value was reported outside of the laboratory.The physician questioned the result, so the sample was repeated, resulting as 5.42 % on (b)(6) 2017.A second sample was collected from the patient and tested, resulting as 5.37 % on (b)(6) 2017.The patient was not adversely affected.The hba1c reagent lot number was 16763301, with an expiration date of 01/31/2018.The field service engineer checked probes and fluidics of the analyzer.It was suspected there may have been an air bubble in the sample.Precision studies were performed.The analyzer was working within specifications.The customer ran calibration and quality controls.The customer was satisfied with the control results.

Manufacturer Narrative

Calibration and quality controls were fine.An issue with the reagent can be excluded due to the fact that other sample results generated around the same time matched original results.A specific root cause could not be determined based on the provided information.The possible root cause may be related to air bubbles in the sample.

• Brand Name: COBAS C513 MODULE
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6705568
• MDR Text Key: 80078851
• Report Number: 1823260-2017-01450
• Device Sequence Number: 0
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060373
• 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
• Report Date: 09/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C513
• Device Catalogue Number: 07649142001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2017
• 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: 25 YR