MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREATININE JAFFE GEN.2; CREATININE, ALKALINE PICRATE COLORIMETRY

Catalog Number 08057532190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

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

Event Date 02/10/2024

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas pro c 503 analytical unit is (b)(6).The field service engineer (fse) inspected the analyzer and determined the event was caused by sample probe s1.The customer replaced this probe.The customer performed qc with acceptable results; the customer also noted abnormal aspiration alarms were resolved.The fse performed mandatory adjustments and verifications of the sample probe after replacement.The investigation is ongoing.

Event Description

The initial reporter received a questionable crej2 creatinine jaffé gen.2 result from one patient sample tested on the cobas pro c 503 analytical unit.The initial result was reported outside of the laboratory.The questionable result was discovered after an additional comprehensive metabolic panel (cmp) was ordered for the patient which included the creatinine assay, prompting the rerun of the patient sample on their other c 503 analyzer.The initial result from the analyzer was 2.1 mg/dl.The repeat result from the other analyzer was 0.7 mg/dl.The repeat result was deemed correct. .

Manufacturer Narrative

Medwatch fields d.Device identification, g1 and g4 pma / 510k (premarket numbers) were updated.The investigation reviewed the last calibration performed on 04-jan-2024; the results were within specifications.The investigation reviewed the qc recovery; the results were within specifications.There was no indication of a performance issue with the reagent.The investigation reviewed the alarm trace; the trace contained "sample probe abnormal aspiration" and "sample foam detection" alarms.These alarms are an indication of possible poor sample quality.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: CREATININE JAFFE GEN.2
• Type of Device: CREATININE, ALKALINE PICRATE COLORIMETRY
• 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: 18855858
• MDR Text Key: 337194562
• Report Number: 1823260-2024-00689
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 07613336121177
• UDI-Public: 07613336121177
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K191899
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08057532190
• Device Lot Number: 747662
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 03/22/2024
• Supplement Dates FDA Received: 04/12/2024
• 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