MAUDE Adverse Event Report: ROCHE MOLECULAR SYSTEMS COBAS AMPLISCREEN HIV TEST; HIV NUCLEIC ACID AMPLIFICATION AND DETECTION

Catalog Number 03322114018

Device Problem False Negative Result (1225)

Patient Problem No Patient Involvement (2645)

Event Date 03/18/2014

Event Type  No Answer Provided  

Event Description

A customer in the us filed a complaint alleging that result discrepancies were generated for one patient sample with the cobas ampliscreen (cas) hiv1 v1.5 test when compared with eia results using ortho and prism platforms.The cas hiv1 test generated non-reactive results in two runs and the eia testing with both platforms generated reactive results.The donor sample was rejected and not released for donation.

Manufacturer Narrative

A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing.The outcome of this investigation will be communicated through a follow-up report.(b)(4).

Manufacturer Narrative

Date of report (b)(6) 2014; date of receipt by manufacturer may 21, 2014; follow up report 1; additional information / device evaluation; device evaluated by manufacturer yes; result code device performed according to specification, conclusion code no failure detected and product within specifications.The complaint alleged that result discrepancies were generated for one patient sample with the cobas ampliscreen (cas) (b)(6) v1.5 test when compared with eia results using ortho and prism platforms.The cas (b)(6) test generated non-reactive results in two runs and the eia testing with both platforms generated reactive results.The donor sample was rejected and not released for donation.Although requested, no sample was available for further investigation; without investigating the complaint sample, the root cause for the discrepant results cannot be identified.The discrepant results in this complaint may be explained by the presence of a low (b)(6) viral titer, differences in the assays' window periods of detection (cas vs eia) and/or differences in the target regions of the various tests used.Retain testing of cas complaint batch generated valid acceptable results.No false non-reactive results were generated during testing.All results met qc release validation and acceptance criteria.These results confirm the complaint kit batch is performing as intended.(b)(4).

• Brand Name: COBAS AMPLISCREEN HIV TEST
• Type of Device: HIV NUCLEIC ACID AMPLIFICATION AND DETECTION
• Manufacturer (Section D): ROCHE MOLECULAR SYSTEMS; 1080 us hw 202s; branchburg NJ 08876 373
• Manufacturer Contact: vincent stagnitto ; 1080 us hwy 202s; branchburg, NJ 08876-3733 ; 9082537569
• MDR Report Key: 3772186
• MDR Text Key: 4377157
• Report Number: 2243471-2014-00008
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 125059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/21/2014

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: 07/31/2014
• Device Catalogue Number: 03322114018
• Device Lot Number: S07137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2014
• Initial Date FDA Received: 04/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1