MAUDE Adverse Event Report: ROCHE DIAGNOSTICS IGG-2; IGG, ANTIGEN

Catalog Number 03507432190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2024

Event Type  malfunction  

Manufacturer Narrative

The c502 module serial number was (b)(6).The competitor method is bn prospec.The samples for patients 1 and 2 contained leucocytes and bacteria.No precipitates were observed in the sample for patient 3.The sample for patient 4 contained erythrocytes.The field service engineer (fse) visited the customer site on (b)(6) 2024 and noted the gear pump pressure was low.The fse replaced the gear pump head and the sample probe.The investigation is ongoing.

Event Description

The initial reporter complained of discrepant high results for 4 patient urine samples tested for igg-2 on a cobas 8000 c 502 module compared to a competitor method.Patient 1 result from the c502 module was 5.9 mg/l.The result from the competitor method was < 3.5 mg/l.Patient 2 result from the c502 module was 11.1 mg/l.The result from the competitor method was 5.7 mg/l.Patient 3 result from the c502 module was 26 mg/l.The result from the competitor method was 11.1 mg/l.Patient 4 result from the c502 module was 7.7 mg/l.The result from the competitor method was < 3.5 mg/l.The samples were run by the competitor method between (b)(6) and (b)(6) 2024.

Manufacturer Narrative

Section d, device identification was updated.Relevant fields of sections d and g were updated.The igg-2 reagent lot number was 771598 with an expiration date of 30-nov-2025.The qc recovery showed imprecision.The measuring range for the urine application of igg-2 is 4.00 - 200 mg/l.Some of the comparison results were below the measuring range of the roche assay.The other comparison results were close to the lower end of the measuring range of the roche assay and could show higher imprecision.After the field service engineer (fse) replaced the gear pump head and adjusted the pressure, the issue improved at the customer site.The gear pump head had not been replaced since the instrument was installed in 2020.The specific cause of the event could not be determined, however, the investigation determined the event was consistent with a maintenance issue.

Manufacturer Narrative

Section h6, additional investigation finding code was provided.

• Brand Name: IGG-2
• Type of Device: IGG, ANTIGEN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18913086
• MDR Text Key: 337769200
• Report Number: 1823260-2024-00768
• Device Sequence Number: 1
• Product Code: DEW
• UDI-Device Identifier: 04015630919710
• UDI-Public: 04015630919710
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K100853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03507432190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• 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
• Patient Sequence Number: 1