MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P 671 CENTRIFUGE UNIT; SPECIMEN PROCESSING INSTRUMENT IVD, AUTOMATED

Catalog Number 07563795001

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2022

Event Type  malfunction  

Event Description

The initial reporter complained that a sample tube broke during centrifugation on a cobas p 671 centrifuge unit.The sample tube broke while it was in a 5-position modular pre-analytics (mpa) rack.A broken sample tube could cause contamination of other samples.There was no allegation of questionable or discrepant results due to this issue.

Manufacturer Narrative

The customer began to use the mpa racks in (b)(6) 2022 with a rotation per minute (rpm) of 4000 and a relative centrifugation force (rcf) of 0 for 6 minutes.Product labeling states, "inspect all mpa racks for cracks, deformation, or breaks.Pay extra attention to the rack¿s first position and its bottom (where the tube base rests on the rack).Immediately discard any defective racks per your local guidelines." product labeling provides the inspection interval depending on a customer¿s centrifuge specifications.The cause of the event could not be determined.The investigation determined that the event was consistent with not regularly checking and replacing the mpa racks.

• Brand Name: COBAS P 671 CENTRIFUGE UNIT
• Type of Device: SPECIMEN PROCESSING INSTRUMENT IVD, AUTOMATED
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15362358
• MDR Text Key: 305606234
• Report Number: 1823260-2022-02736
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07563795001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2022
• 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
• Patient Sequence Number: 1