MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS, INC COBAS TAQSCREEN MPX TEST, V2.0 CE-IVD

Catalog Number 05969492190

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

An (b)(6) customer alleged the generation of a (b)(6) result with the cobas taqscreen mpx test v2.0 ce-ivd (lot 225191) for a donor sample, when tested in a pool of 1.The donor sample generated (b)(6) serology results for (b)(6) and upon repeat testing with the cobas taqscreen mpx test v2.0 ce-ivd (lot 225191), an (b)(6) reactive result was obtained.The blood associated with this donor was discarded and no harm was alleged.Through the course of the investigation, sample was requested from the customer for further testing; however, as the blood was discarded there was no additional sample left.The retain kit lot (225191) was tested and met specifications; no (b)(6) results were generated.No kit issues were identified in the review of the qc kit release data generated for this lot, and there were no related internal non-conformances.Possible issues that could lead to no amplification of targets or suppression of the ic include work flow issues during sample prep, dust, contamination or other pcr inhibitors (e.G.Heparin, dna away).The udi for the cobas taqscreen mpx test, v2.0 ce-ivd is (b)(4).The corresponding us kit material number is (b)(4).(b)(4).

Event Description

A customer in (b)(6) reported a result discrepancy during use of the mpxv2 assay.On (b)(6) 2017 the customer tested a pp6 which generated a (b)(6) result for (b)(6) (ct.23.2).Resolution pooling (resp1) was performed on (b)(6) 2017 and all samples in the pool generated (b)(6) results.Due to the fact that serology was (b)(6) for the donor, on (b)(6) 2017, a new aliquot (from the same withdrawal) was tested in pp1.

• Brand Name: COBAS TAQSCREEN MPX TEST, V2.0 CE-IVD
• Type of Device: NA
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS, INC; 1080 us highway 202 south; branchburg NJ 08876
• Manufacturer Contact: stacie-ann creighton ; 1080 us hwy 202 s; na; branchburg, NJ 08876 ; 9082537112
• MDR Report Key: 6789403
• MDR Text Key: 83108701
• Report Number: 2243471-2017-00020
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/11/2017

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 Expiration Date: 08/31/2018
• Device Catalogue Number: 05969492190
• Device Lot Number: 225191
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2017
• Initial Date FDA Received: 08/11/2017
• 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