MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 C 702 MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C702

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of discrepant ureal urea/bun (bun) for one patient sample.The initial sample was aliquoted by a modular pre-analytics (mpa) and bun testing was performed with an initial result of 129 mg/dl accompanied with a data flag.The sample was automatically rerun diluted by the analyzer and a result of 130 mg/dl was obtained.The primary collection tube was then run on another cobas 8000 c 702 module (c702) and a bun result of 8 mg/dl was obtained.The result from the other c702 was deemed to be correct.The discrepant results were not reported outside of the laboratory.There was no adverse event.The bun reagent lot was 19683601 with an expiration date of 31-aug-2017.This medwatch will cover the c702 module.Refer to medwatch (b)(4) for information on the mpa.The field engineering specialist was unable to find a cause for the malfunction.He performed system operational checks all which passed.He deemed the system operational.A historical query for this site was performed and no new or past escalated complaints of this nature on any like instruments were found for the past 12 months.

Manufacturer Narrative

The root cause could not be identified.As calibration and qc data were acceptable a general issue with the reagent can be excluded.A possible contamination of the modular pre-analytics cup could have caused the high result.The customer was also not using the recommended rack adapters which could have caused the tubes to be not correctly aligned vertically which may lead to false results.

• Brand Name: COBAS 8000 C 702 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: 6882060
• MDR Text Key: 89242136
• Report Number: 1823260-2017-02028
• Device Sequence Number: 0
• Product Code: CDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C702
• Device Catalogue Number: 06473245001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2017
• 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: 46 YR