MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P 612 PRE-ANALYTICAL SYSTEM; AUTOMATED PREANALYTICAL SYSTEM

Model Number P612

Device Problem Non Reproducible Results (4029)

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

Event Date 01/17/2022

Event Type  malfunction  

Event Description

The initial reporter received false-positive cobas epstein-barr virus (ebv) results for two patients tested on two cobas 6800 systems that were initially processed on a cobas p 612 pre-analytical system.The cobas 6800 systems had serial numbers of (b)(4).The ebv reagent lot numbers were h21170 and h24625.The false-positive results were reported outside the laboratory.Based on the reported results, the two patients had their immunosuppressive medication altered.The accuracy of the reported ebv results were questioned by medical personnel after the patients had new samples collected and tested for ebv and recovered "different results." (b)(6).The serial number was unknown.

Manufacturer Narrative

The customer found that the samples processed on the cobas p 612 pre-analytical system formed a red blood cell "pellet" at the bottom of the tube during sample storage in the refrigerator, indicating blood cells were left in the sample.The customer reported the samples are refrigerated for up to 5 days and then frozen.The field service engineer performed preventative maintenance and found an issue where a tube didn't get into the primary tube transport (ptt) start position correctly and was hitting the tube holder's edge.He also found the air displacement pipettor (adp) hit a secondary tube's edge while dispensing.He performed adjustments to the system and confirmed the system was operational.After service, the customer reported there were no more pellets at the bottom of the sample tubes.After service, no further issues were reported by the customer.The system log files were requested but not available to be provided.The investigation did find any indication of incorrect sample handling.The investigation is ongoing.

Manufacturer Narrative

Based on the provided information, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS P 612 PRE-ANALYTICAL SYSTEM
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14013902
• MDR Text Key: 298334935
• Report Number: 1823260-2022-00954
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P612
• Device Catalogue Number: 07563116001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 04/11/2022
• Supplement Dates FDA Received: 04/28/2022
• 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