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

Catalog Number 04912551190

Device Problem High Test Results (2457)

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

Event Date 02/20/2021

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6) unique device identifier (udi) (b)(4).The samples were requested but not available for investigation.The customer's calibration data was ok.The customer's qc data contained results with a high coefficient of variation.The investigation reviewed the customer's alarm trace and noticed frequent cell blank errors, which reflected to poor system maintenance.The customer's sample pre-analytical handling details were requested but not provided.Per product labeling, "high concentrations of d-fragments, as can occur during lysis therapy, lead to depressed measurements.In very rare cases, gammopathy, in particular type igm (waldenström¿s macroglobulinemia), may cause unreliable results.In rare cases (less than 1 reported case per 100000 tests) certain immunoglobulins can cause a non-specific agglutination leading to falsely high result." results can differ between tests due to the different specificity of the antibody used or other test characteristics.The investigation did not identify a product problem.The cause of the event could not be determined.

Event Description

The initial reporter received questionable d-dimer results for three patients tested on two cobas 4000 c (311) stand alone systems with serial numbers (b)(4) and (b)(4).The initial d-dimer results from the c (311) with a serial number of (b)(4) were reported outside the laboratory.The therapist complained to the laboratory due to the initial results not matching the clinical picture of the patients.The customer performed repeat testing with the samples on a vidas analyzer, a g10 3500 instrument, and with manual latex methodology for confirmation.On (b)(6) 2021, patient 1's c (311) d-dimer result was 1.35 ug/ml with serial numbers (b)(4) and (b)(4).Patient 1's d-dimer result on the vidas analyzer was 0.43 ug/ml.Patient 1's d-dimer results on the g10 3500 instrument and with manual latex methodology were "negative." on (b)(6) 2021, patient 2's c (311) d-dimer result was 3.03 ug/ml with serial numbers (b)(4) and (b)(4).Patient 2's repeat result on the c (311) serial number (b)(4) was 2.37 ug/ml.Patient 2's d-dimer result on the vidas analyzer was 0.47 ug/ml.Patient 2's d-dimer results on the g10 3500 instrument and with manual latex methodology were "negative." on (b)(6) 2021, patient 3's initial d-dimer result on the vidas analyzer was "<0.10" mg/l.On (b)(6) 2021, patient 3's c (311) d-dimer result with serial number (b)(4) was 1.83 ug/ml with a data flag.On (b)(6) 2021, the customer performed dilution testing with the patient's sample on the c (311) with serial number (b)(4).At 13:55, the patient's d-dimer result with "dilution by volume decrease" was 0.11 ug/ml with a data flag.The c (311) performed an automatic rerun, and the patient's d-dimer result was 1.93 ug/ml.At 15:51, the customer performed a 1:2 manual dilution and the patient's d-dimer result was 0.60 ug/ml.At 20:21, the customer performed a 1:3 manual dilution and the patient's d-dimer result was 0.39 ug/ml.Patient 3's d-dimer results on the g10 3500 instrument and with manual latex methodology were "negative.".

• Brand Name: D-DIMER
• Type of Device: FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 11542738
• MDR Text Key: 246265620
• Report Number: 1823260-2021-00884
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K062203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2021

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: 11/30/2021
• Device Catalogue Number: 04912551190
• Device Lot Number: 50914501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2021
• Initial Date FDA Received: 03/22/2021
• 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