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

Model Number P612

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/31/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer complained of high results for 1 patient tested for hcg + b on a cobas 6000 e 601 module that did not fit the patient's clinical picture.The customer thinks the sample producing the high result was contaminated by the cobas p 612 pre-analytical system when the sample tube was decapped and placed in the rack.Afterwards, the user took the rack and placed it into the e601 module.This medwatch will cover the p612 system.Refer to medwatch with patient identifier (b)(6) for information on the e601 module.The initial hcg + b result was 800.9 miu/ml.This result was reported outside of the laboratory.The high result was "not possible" for this patient.On (b)(6) 2018 a new sample was obtained and the hcg + b result was < 5 miu/ml.The initial sample was repeated and the "same" high result was obtained.The actual result was not provided.The 2nd sample from (b)(6) 2018 was repeated and a similar low result was obtained.The actual result was not provided.The low results were believed to be correct.There was no allegation that an adverse event occurred.The hcg + b reagent lot number was 308599.The expiration date was not provided.The field service engineer (fse) visited the customer site to check both the e601 module and the p612 system.No issues were identified on either system.Calibration and qc were acceptable on the e601 module.Analyzer performance data from (b)(6) 2018 was acceptable.A clear root cause was not identified by the fse.Investigations are ongoing.

Manufacturer Narrative

The log files were analyzed and the actions the device performed were reconstructed.No errors were detected.The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

The field service engineer (fse) and field application specialist (fas) visited the customer site on (b)(6) 2018 and performed multiple contamination tests on the p612 system.Prior to performing the tests, the entrance and exit areas of the system were cleaned.During the testing performed by the fse and fas, no contamination was observed.

Manufacturer Narrative

During the investigation the log files were reviewed and the actions of the p612 were reconstructed.The tube with the patient id was initially sorted on (b)(6) 2018 at 10:23 a.M.And later again at 1:17 p.M.For verification.The first time (10:23 a.M.), the sample tube was only de-capped and sorted to workplace titled cobas_cee on rack 8 of the p612 system.Afterwards, the sample tube was put on the e601 module manually by laboratory staff.The e601 module resulted at 800.9 miu/ml.The 2nd time (1:17 p.M.), the sample tube was used to create an aliquot.The aliquot was sent to workplace titled serot.The same incorrect high result was measured on the e601 module.No system errors occurred that would cause cross-contamination.No accidents (like spillage or sorting problems) were reported by the customer.The sample tube was de-capped and sorted by the p612 system with no problems.Cross-contamination was not caused by the p612 instrument.

• Brand Name: COBAS P 612 PRE-ANALYTICAL SYSTEM
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• MDR Report Key: 7805182
• MDR Text Key: 118099878
• Report Number: 1823260-2018-02824
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 04015630926305
• UDI-Public: 4015630926305
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/09/2018

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
• Initial Date Manufacturer Received: 08/01/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 08/01/2018; 08/01/2018; 08/01/2018
• Supplement Dates FDA Received: 09/07/2018; 09/24/2018; 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR