MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CMV IGG; ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS

Catalog Number	07027117190
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys cmv igg results for one patient tested on a cobas 8000 e 801 module serial number (b)(4).The patient had two samples collected.The patient's elecsys cmv igg results were reported outside the laboratory.The patient's samples were repeated on a vidas analyzer and a liaison analyzer.On (b)(6) 2022, the patient's first sample was collected.The patient's elecsys cmv igg result was 2.5 u/ml positive.The patient's vidas cmv igg result was 0.135 ua/ml negative.On (b)(6) 2022, the patient's second sample was collected.The patient's elecsys cmv igg result was "<1" u/ml negative.The patient's vidas cmv igg result was 19 ua/ml positive.The patient's liaison cmv igg result was 63 u/ml positive.
Additional Manufacturer Narrative
The patient's sample was not available for investigation.Based on the provided information, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS CMV IGG
• Common Device Name: ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS
• 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: 14208719
• Report Number: 1823260-2022-01184
• Device Sequence Number: 4357600
• Product Code: LFZ
• UDI-Device Identifier: 04015630940172
• UDI-Public: 04015630940172
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K131605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2022

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 Expiration Date: 09/30/2022
• Device Catalogue Number: 07027117190
• Device Lot Number: 56805401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 04/26/2022
• Supplement Report FDA Received Date: 06/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown