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

Model Number C702

Device Problem Low Test Results (2458)

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

Event Date 05/21/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received erroneous results for three patient samples tested for bilt3 bilirubin total gen.3 (tbil) on a cobas 8000 c 702 module (c702).Of the three samples, one had an erroneous result that was reported outside of the laboratory.The sample initially resulted as 0 umol/l and this value was automatically released to the lis and the requesting doctor.The doctor realized that the result was erroneous and requested repeat testing.The repeat result was 236.7 umol/l and this value was reported outside of the laboratory.No adverse events were alleged to have occurred with the patient.The tbil reagent lot number was 201416.The reagent expiration date was asked for, but not provided.Tbil calibrations are performed daily and have been very steady.Erroneous low results for the two other patient samples were found by the customer on (b)(6) 2017.While investigating this occasion, the field service engineer found that the customer was running the samples in the same rack in micro-cups on top of false bottom tubes.The engineer also found that the sample probe was dirty, possibly with gel.He replaced the probe and re-aligned it.

Manufacturer Narrative

The analyzer sample probe was unusually contaminated above the tip.The probe also was misadjusted.Investigations conclude that the misalignment of the sample probe caused contamination of the probe, leading to the event.

• 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: 6637788
• MDR Text Key: 77641891
• Report Number: 1823260-2017-01228
• Device Sequence Number: 0
• Product Code: MQM
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• 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: 05/30/2017
• 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: 2 DA