MAUDE Adverse Event Report: ROCHE DIAGNOSTICS VALP VALPROIC ACID; ENZYME IMMUNOASSAY, VALPROIC ACID

Catalog Number	20737933322
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred in (b)(6).
Event or Problem Description
The customer questioned results for 1 patient tested for valp valproic acid (valp) on a cobas integra 400 plus.The initial result was 345 ug/ml.The sample was diluted 1:2 and the result was 344 ug/ml.A new sample was obtained on (b)(6) 2018 and the result was 160 ug/ml.These results were believed to be too high.The customer suspects an interference.The results were reported outside of the laboratory.There was no allegation that an adverse event occurred.The integra 400 plus serial number was (b)(4).
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: VALP VALPROIC ACID
• Common Device Name: ENZYME IMMUNOASSAY, VALPROIC ACID
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7890647
• Report Number: 1823260-2018-03208
• Device Sequence Number: 16825872
• Product Code: LEG
• UDI-Device Identifier: 04015630915958
• UDI-Public: 04015630915958
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K951595
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: 20737933322
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/03/2018
• Supplement Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 11/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1