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

Catalog Number	07027117190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received a questionable elecsys cmv igg result for one patient sample with cobas e 801 module (b)(4).The initial result was 1.20 u/ml (reactive).This result was reported outside of the laboratory and questioned by the doctor.On (b)(6) 2021, the sample was tested in another laboratory on an unknown analyzer with a result of negative (non-reactive).
Additional Manufacturer Narrative
The sample was requested for investigation.
Additional Manufacturer Narrative
The customer's calibration and qc results were within specification.The customer's sample pre-analytic details were requested but not provided.The result of the customer could be confirmed.Further investigation suggests that the sample is consistent with a false positive in the elecsys cmv igg assay.Based on data presented in product labeling, single false positives can occur.The reagent performs within specification.A general product problem was not found.

• Brand Name: ELECSYS CMV IGG ASSAY
• 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: 12793606
• Report Number: 1823260-2021-03328
• Device Sequence Number: 5718321
• Product Code: LFZ
• UDI-Device Identifier: 04015630940172
• UDI-Public: 04015630940172
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K131605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 02/16/2022

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: 568054
• 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: 10/21/2021
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 02/16/2022
• 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: Female