MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MPA; AUTOMATED PREANALYTICAL SYSTEM

Model Number MPA

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The customer complained of erroneous results for 2 patient samples that were tested for crej2 creatinine jaffé gen.2 (crej2) and ureal urea/bun (ureal) on a cobas 8000 c 702 module and elecsys ft4 ii assay (ft4 ii) and elecsys tsh assay (tsh) on a cobas 8000 e 602 module.The initial results were run on (b)(6) 2017 and reported outside of the laboratory.The erroneous results were identified when repeat testing was performed on (b)(6) 2017.The customer thought the issue could be related to the modular pre-analytic (mpa) system because they received an error around the time of the incident.The customer was asked, but did not provide, which results came from an aliquot sample and which came from the primary sample.This medwatch will cover the mpa.(b)(4).Patient 1 had an initial ureal result on the c702 module of 42 mg/dl and an initial crej2 result of 8.64 mg/dl on the c702 module.Patient 1 also had an initial tsh result of 4.47 uiu/ml on the e602 module.The sample was repeated and the ureal result on a c702 modu was 18 mg/dl and the crej2 result on a c702 module was 1.05 mg/dl.The tsh repeat result from an e801 module was 2.72 uiu/ml.Patient 2 had an initial ft4 ii result on the e602 module of.505 ng/dl and an initial tsh result from the e602 module of 0.356 uiu/ml.The sample was repeated on an e801 module and the ft4 ii result was 2.17 ng/dl or 2.1 ng/dl and the tsh result was 22.4 uiu/ml or 22.62 uiu/ml.Clarification on the correct results has been requested but not provided.No adverse event occurred.The field service engineer (fse) visited the customer site where a cause was not identified.The mpa produced a 570 stopper error and the stopper mechanism was replaced on (b)(6) 2017.A stopper error occurs when feeding racks into the aliquot module.This error does not affect the aliquot of samples.The aliquot module was operating according to manufacturer specification.During the service visit it was suggested that hitachi cups may not have been discarded from the aliquot rack prior to using the mpa aliquoter potentially causing patient samples to become mixed on the rack.Data was provided mentioning 5 patient samples that were potentially affected.It is not clear whether these 5 patient samples are part of the 2 patient samples the customer initially complained about.Clarification has been requested but has not been provided.It was noted that 1 patient sample was repeated because the doctor called and questioned the results.The results for patient 2 were questioned by a patient care provider on a different day, but the sample for patient 2 was discarded.It was noted that the customer was able to retest another sample from this patient but they were not able to report all the results.While investigating the issue, 3 more patient samples were identified as possibly being affected due to comparing the patients' most recent test results with their previous test results.The customer provided an example of a patient tested for vanc where they had been running around 15 ug/dl and the result after their last dose was < 4 ug/dl.Clarifications surrounding the additional patient samples was requested but has not been provided.It is not known if discrepant results were generated or if incorrect results were reported outside of the laboratory.Investigations are ongoing.

Manufacturer Narrative

Clarification was provided for the results for patient 2.Patient 2 had an initial ft4 ii result on the e602 module of 0.505 ng/dl and an initial tsh result from the e602 module of 0.36 uiu/ml.The sample was repeated on an e801 module and the ft4 ii result was 2.1 ng/dl and the tsh result was 22.62 uiu/ml.The repeat results were believed to be correct for both patients.

Manufacturer Narrative

A specific root cause was not identified.No alarms occurred on the mpa on the day of the event and the patient samples were processed as normal.There is no indication that this event was caused by a malfunction of the mpa system.

• Brand Name: MPA
• 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: 7037538
• MDR Text Key: 93355785
• Report Number: 1823260-2017-02628
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2018

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: MPA
• Device Catalogue Number: 05005256002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2017
• Initial Date FDA Received: 11/16/2017
• Supplement Dates Manufacturer Received: 10/23/2017; 10/23/2017
• Supplement Dates FDA Received: 11/17/2017; 01/11/2018
• 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