MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ANTI-HAV; HEPATITIS A TEST

Catalog Number 04854977190

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer received questionable elecsys (b)(6) assay gen 2 results for one patient sample upon dilution.The results undiluted were 40 iu/l and 42.41 iu/l.With a 1:2 dilution, the result was (48.22) 96.44 iu/l.With a 1:6 dilution, the result was (51.58) 309.48 iu/l.With a 1:10 dilution, the result was (51.25) 512.5 iu/l.With a 1:20 dilution, the result was (48.84) 976.8 iu/l.With a 1:40 dilution, the result was (37.58) 1503.2 iu/l.With a 1:100 dilution, the result was (17.69) <20 iu/l ((b)(6)).Information concerning if any erroneous result was reported outside of the laboratory was requested, but it was unknown.There was no allegation of an adverse event.The customer used a cobas e 411 immunoassay analyzer.The serial number was requested but was not provided.

Manufacturer Narrative

Internal control samples were tested with the anti-hav reagent and the results were within specification.Therefore, a general malfunction of the assay was excluded and the issue was found to be sample specific.The investigation could not determine a specific root cause due to insufficient sample volume available for investigation.

• Brand Name: ANTI-HAV
• Type of Device: HEPATITIS A TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7439197
• MDR Text Key: 105765889
• Report Number: 1823260-2018-01198
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• PMA/PMN Number: K100903
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04854977190
• Device Lot Number: 283241
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1