MAUDE Adverse Event Report: ROCHE DIAGNOSTICS D-DIMER; FIBRIN SPLIT PRODUCTS

Catalog Number 04912551190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for an unspecified number of patient samples tested with d-di tina-quant d-dimer on a cobas 6000 c (501) module.The reporter states that samples with initial d-dimer values above 6 ug/dl repeat with values higher than the assay measuring range (0.15-9.00 g /ml) when diluted.The reporter provided specific data for two patient samples.No incorrect results were reported outside of the laboratory.The first sample initially resulted with a d-dimer value of 6.43 ug/ml on the c501 analyzer.The result was questioned and was repeated on a mini vidas analyzer, resulting with a value of > 10 ug/ml.The sample was then diluted and repeated on the mini vidas, resulting with a value of 66 ug/ml.The sample was then repeated with decreased sample volume on the c501 analyzer, resulting with a value of 18.50 ug/ml.The sample was then automatically diluted 1:10 and repeated on the c501 analyzer, resulting with a value of 69.67 ug/ml.The second sample was initially tested on the c501 analyzer, resulting with a d-dimer value of 8.14 ug/ml.The sample was automatically diluted 1:10 and repeated on the c501 analyzer, resulting with a value of 30.40 ug/ml.The sample was repeated with decreased sample volume on the c501 analyzer, resulting with a value of 19.48 ug/ml.The c501 analyzer serial number is (b)(4).

Manufacturer Narrative

The customer's provided calibration and qc recovery were ok.Based on calibration and qc data a general reagent issue could be excluded.The instrument alarm trace showed multiple abnormal probe sucking alarms.Per the method sheet's limitations - interference section "high concentrations of d-fragments, as can occur during lysis therapy, lead to depressed measurements.In rare cases, igm, particularly in samples from patients with myeloma, can give falsely high results." the investigation found the patient samples were from covid-19 patients.Covid-19 patients may show high plasmin activation.Based on the higher patient results due to higher dilution, the investigation found the root cause to be interference.The investigation did not identify a product problem.

• Brand Name: D-DIMER
• Type of Device: FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10808412
• MDR Text Key: 215311917
• Report Number: 1823260-2020-02812
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• PMA/PMN Number: K062203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

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 Expiration Date: 10/31/2021
• Device Catalogue Number: 04912551190
• Device Lot Number: 497028
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1