MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Model Number C501

Device Problem Low Test Results (2458)

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

Event Date 08/23/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer questioned low direct bilirubin (bild2) and bilt3 bilirubin total gen.3 (bilt3) results for 1 patient sample tested on a cobas 6000 c (501) module.Based on the data provided, the total bilirubin results were erroneous.The erroneous results were not reported outside of the laboratory.The initial bilt3 result from a hitachi cup was 16.8 (unit of measure not provided).The repeat result was 235.There was no allegation that an adverse event occurred.The bilt3 reagent lot number and expiration date were not provided.The customer cleans the sample probe every day with alcohol.A specific root cause was not identified.The system has run with no further deviations since this one occurrence.Based on the reaction curve provided, sample was missing from the reaction.Bilt3 is sensitive to disturbances due to a partly clogged sample probe.A review of the customer¿s service history did not suggest any pre-analytical issues.A possible root cause may be that a prior sample was not centrifuged long enough or a sample that tends to clot after centrifugation caused a micro clot, but this cannot be confirmed.

• Brand Name: COBAS 6000 C (501) 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: 6864147
• MDR Text Key: 87231003
• Report Number: 1823260-2017-01973
• Device Sequence Number: 0
• Product Code: MQM
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060373
• 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: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C501
• Device Catalogue Number: 04745914001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2017
• Initial Date FDA Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1