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

Model Number C702

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).Unique identifier (udi)#: (b)(4).

Event Description

The customer complained of erroneous results for 1 patient sample tested for alt alanine aminotransferase acc.To ifcc without pyridoxal phosphate activation (alt) and ast aspartate aminotransferase acc.To ifcc without pyridoxal phosphate activation(ast) on two cobas 8000 c 702 modules.Erroneous results were reported outside of the laboratory.This medwatch will cover c702 module with serial number (b)(4) (c702 module a).Refer to medwatch with (b)(6) for information on the c702 module with serial number (b)(4) (c702 module b) erroneous results.On (b)(6) 2017 the patient was initially tested on c702 module b and the ast result was 518.6 u/l.This result was reported outside of the laboratory.On (b)(6) 2017 the doctor asked for the sample to be repeated.The sample was repeated on c702 module a and the ast result was 566.6 u/l.The sample was then repeated on c702 module b and the ast result was 4467.8 u/l.The sample was repeated in decrease mode and the ast result from c702 module a was 292.9 u/l.On (b)(6) 2017 the patient was initially tested on c702 module b and the alt result was 232.9 u/l.The sample was repeated on c702 module b and the alt result was 5917.3 u/l.The sample was repeated in decrease mode and the alt result from c702 module b was 5902.3 u/l.The ast result of 292.9 u/l and the alt result of 5902.3 u/l were reported outside of the laboratory where the patient (who happens to be a doctor) questioned the low ast result.The ast result of 4467.8 u/l was believed to be correct.Two new samples were obtained on (b)(6) 2017 and the ast results were both > 4000 u/l.There was no allegation that an adverse event occurred.The last monthly maintenance prior to the event was performed on (b)(6) 2017 where cuvettes and the photometer were replaced.Calibration and quality controls were acceptable.A specific root cause was not identified.Additional information was requested for investigation but was not provided.Since calibration and qc were acceptable, both an instrument and reagent problem can be excluded as a root cause.The customer has not complained of any additional issues.

• 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: 6817765
• MDR Text Key: 83862590
• Report Number: 1823260-2017-01811
• Device Sequence Number: 0
• Product Code: CIT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C702
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/07/2017
• 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