MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREJ2; ALKALINE PICRATE, COLORIMETRY, CREATININE

Catalog Number 04810716190

Device Problem Low Test Results (2458)

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

Event Date 12/03/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The field service engineer (fse) cleaned the splash guard and syringes, cleaned the internal and external water reservoirs, and performed system primes.The investigation is ongoing.

Event Description

There was an allegation of questionable crej2 creatinine jaffé gen.2 results for 4 patient samples on a cobas integra 400 plus module compared to a diasys respons920 analyzer.On (b)(6) 2023, sample 1 had an initial creatinine result of 6.36 mg/dl.The sample was repeated on a respons920 analyzer and the result was 12.8 mg/dl.On (b)(6) 2023, the sample was repeated two more times on the cobas integra and the results were 11.68 mg/dl and 11.67 mg/dl.On (b)(6) 2023, sample 2 had an initial creatinine result of 0.4 mg/dl.The sample was repeated on a respons920 analyzer and the result was 7.4 mg/dl.On (b)(6)2023, the sample was repeated two more times on the cobas integra and the results were 7.59 mg/dl and 7.6 mg/dl.On (b)(6) 2023, sample 3 had an initial creatinine result of 7.6 mg/dl.The sample was repeated on a respons920 analyzer and the result was 5.85 mg/dl.On (b)(6) 2023, the sample was repeated two more times on the cobas integra and the results were 7.96 mg/dl and 7.99 mg/dl.On (b)(6) 2023, sample 4 had an initial creatinine result of 4.8 mg/dl.The sample was repeated on a respons920 analyzer and the result was 7.4 mg/dl.On (b)(6) 2023, the sample was repeated two more times on the cobas integra and the results were 6.57 mg/dl and 6.6 mg/dl.The respons920 results were deemed correct.

Manufacturer Narrative

Section d product information has been updated, as well as g1 manufacturing site and g4.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: CREJ2
• Type of Device: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE INSTRUMENT CENTER AG TEGIMENTA; forrenstrasse; rotkreuz 6343 ; WZ 6343
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18364798
• MDR Text Key: 330999757
• Report Number: 1823260-2023-04134
• Device Sequence Number: 1
• Product Code: CGX
• UDI-Device Identifier: 04015630922284
• UDI-Public: 04015630922284
• Combination Product (y/n): Y
• Reporter Country Code: EG
• PMA/PMN Number: K951595
• 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: 02/22/2024
• 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: 04810716190
• Device Lot Number: 72593401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1