MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CREJ2 CREATININE JAFFÉ GEN.2; ALKALINE PICRATE, COLORIMETRY, CREATININE

Model Number CREAJ

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

The customer stated that they have seen this issue for a year.The customer believes the issue is resolved by either high centrifugation of the patient samples or letting the patient samples sit for greater than 24 hours.The customer considers the results obtained after performing these steps more consistent with the patient's clinical pictures and historical results.The investigation is currently ongoing.The event occurred in: (b)(6).

Event Description

The initial reporter complained of questionable results for multiple patients from two cobas 8000 c 702 modules and one cobas 6000 c (501) module.The customer believes that the patient's results are being affected by lipemia in the blood sample.From the data provided: 3 patients had questionable crej2 creatinine jaffé gen.2, trigl triglycerides, and chol2 cholesterol gen.2 results.1 patient had questionable crej2 and trigl results.6 patients had questionable crej2 results.1 patient had questionable hdlc4 hdl-cholesterol plus 4th generation, trigl, and chol2 results.2 patients had questionable trigl results.5 patients had questionable trigl and chol2 results.The date of the event is the earliest known date that a questionable patient result was obtained.The customer indicated that this has been an ongoing issue.This medwatch will cover crej2.For hdlc4, trigl, and chol2 refer to the med watches with patient identifiers (b)(6) respectively.The customer verified that there was no allegation of any adverse events for any patients.The customer did not specify which results were from which analyzers.But they did provide the following instrument serial numbers: cobas c702 (b)(4), cobas c702 (b)(4), and cobas c501 (b)(4).

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

Q: is lipemia a known interfering condition for creatinine jaffé gen.2 assay? a: there is a lipemia interference above an l-index of 800.The following statement is in the limitations - interference section of the creaj2 instructions for use for cobas c analyzers:: lipemia (intralipid): no significant interference up to an l index of 800.There is poor correlation between the l index (corresponds to turbidity) and triglycerides concentration.Q: in the mdr supplement 1 it is stated that the investigation did not identify a product problem.What kind of investigation was conducted? a: the customer provided data to roche.This data was analyzed.Also, a conference call was held with the customer and with members of roche r&d, complaint investigation & resolution unit and the uk affiliate organization in which the customer's issue and data were discussed.It was requested that the customer perform structured measurements, collect data and provide the results along with samples to roche for additional analysis.It was also requested to complete the pre-analytical checklist in order to rule out sample handling issues.If additional information is provided further investigation will take place.Q: it is stated that the customer believes the issue is resolved by either high centrifugation of the patient samples or letting the patient samples sit for greater than 24 hours.Is this a sample workout recommended in the product labeling? a: this work-around is not defined in the product labeling.This work-around was created by the customer.Q: does the customer continue to have issues? a: we have not received additional complaints from the customer.

• Brand Name: CREJ2 CREATININE JAFFÉ GEN.2
• Type of Device: ALKALINE PICRATE, COLORIMETRY, CREATININE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9075467
• MDR Text Key: 219201768
• Report Number: 1823260-2019-03319
• Device Sequence Number: 1
• Product Code: CGX
• Combination Product (y/n): N
• PMA/PMN Number: K951595
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2020

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
• Device Operator: Health Professional
• Device Model Number: CREAJ
• Device Catalogue Number: 06407137190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 08/23/2019; 08/23/2019
• Supplement Dates FDA Received: 03/04/2020; 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1