MAUDE Adverse Event Report: ROCHE DIAGNOSTICS HCYS HOMOCYSTEINE ENZYMATIC ASSAY; HOMOCYSTEINE TEST

Catalog Number 06542921190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The customer has discarded the reagent.

Event Description

The customer initially questioned quality control (qc) results when they received new reagent lot number 173121 for the hcys homocysteine enzymatic assay (hcys).The customer performed comparison tests using the new reagent lot and the old reagent lot with patient samples and no differences were observed.Afterwards, the customer began to use the new reagent lot.Over time, their qc results began to drift and the customer decided not to run hcys tests with reagent lot 173121 until they received new reagents.Around this time the customer received communication from the manufacturer about reagent lot 173121.Due to this communication, the customer reviewed the median of the patient results tested for hcys and noticed the median had dropped.The customer concluded that they may have released incorrect, low hcys results.The customer has contacted medical personnel and informed them that the actual hcys patient results may not be as low as the results indicate.No specific results were provided and no patient information was provided.The customer provided a median result from (b)(6) 2016 of 13.261 umol/l and a median result from (b)(6) 2016 of 9.652 umol/l.No adverse event occurred.The cobas 8000 c (701) module serial number was not provided.The customer has discarded the reagent.

Manufacturer Narrative

An issue with reagent lot 173121 resulting in under recovery of quality control and patient sample results has been confirmed by the investigation.The hcys lot number in this case is not distributed in the united states, therefore, this issue does not affect customers in the united states.

• Brand Name: HCYS HOMOCYSTEINE ENZYMATIC ASSAY
• Type of Device: HOMOCYSTEINE TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6154282
• MDR Text Key: 61737070
• Report Number: 1823260-2016-01916
• Device Sequence Number: 1
• Product Code: LPS
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K113793
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: 06542921190
• Device Lot Number: 173121
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2016
• 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