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

Model Number P612

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 02/02/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer stated that a sample aliquoted by the cobas p 612 pre-analytical system (p612) had electrophoresis results which did not match results obtained with the primary tube of the sample.Erroneous results were reported outside of the laboratory to the doctor.The patient is a known myeloma patient with igg kappa, but the electrophoresis results showed no bands when the aliquot sample processed by the p 612 system was tested.A repeat of this same aliquot also showed no band.When the primary tube was tested, an abnormal band indicating myeloma was observed.The customer believes that the wrong sample went into the aliquot tube.It is not known if this was related to a human error or if this was an issue with the p 612 system.The customer mentioned that around the time the sample was processed, they were having a separate issue with the foil applicator of the p 612 system.Due to this issue, several tubes were manually aliquoted.The staff checked the p 612 system software and it showed that the affected sample was aliquoted by the system and the aliquot tube went to a tray designated for electrophoresis testing.The customer stated that no errors occurred at the time the sample was processed.No adverse events were alleged to have occurred with the patient.

Manufacturer Narrative

The investigation determined the processing steps for the affected sample (sample id: (b)(6)) were performed correctly.The steps include: barcode reading: creation of the aliquot tube.Pipetting from primary sample to aliquot sample (550 ul).Recapping of aliquot sample.Sorting of primary sample to target.During the time the sample was being processed, the instrument was experiencing issues with the recapper module.Troubleshooting was being performed on the instrument at the time of issue.The available log files show the aliquot was transported manually by the operator to the analyzer because this sample is not visible on the log files of the outsort area.The steps performed on the instrument p612 were correct.An unforeseen human intervention cannot be excluded.The investigation was unable to find a definitive root cause.

• 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): 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: 7302189
• MDR Text Key: 101574838
• Report Number: 1823260-2018-00596
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: EXEMPT
• 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: 08/01/2018

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: 05082579001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 02/08/2018
• Supplement Dates FDA Received: 08/01/2018
• 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: 55 YR