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

Catalog Number 04912551190

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

The instrument lamp and probes were checked, along with calibration, qc and reagent materials.No issues were identified.The investigation is ongoing.

Event Description

The initial reporter complained of discrepant results for 1 patient sample tested for d-dimer on a cobas integra 400 plus.The initial result from the integra 400 plus was 2085 ng/ml.The repeat result on the integra 400 plus was 1371 ng/ml.The sample was repeated on the integra 400 plus again with a result of 3648 ng/ml.The sample was sent to an external laboratory where the result using an immunoturbidimetry method was 3446.3 ng/ml.Following the result from the other laboratory, the result of 3648 ng/ml was believed to be correct and was reported outside of the laboratory.No questionable results were reported outside of the laboratory.The integra 400 plus serial number was (b)(4).

Manufacturer Narrative

The patient was positive for covid-19.The investigation determined the event was consistent with an interference by d-fragment.Product labeling states: "high concentrations of d-fragments, as can occur during lysis therapy, lead to depressed measurement." the investigation did not identify a product problem.

• Brand Name: D-DIMER
• Type of Device: FIBRIN SPLIT PRODUCTS
• MDR Report Key: 12575304
• MDR Text Key: 274784090
• Report Number: 1823260-2021-02900
• 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: 10/26/2021

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: 06/30/2022
• Device Catalogue Number: 04912551190
• Device Lot Number: 53822501
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/05/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 10/26/2021
• 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
• Patient Age: 72 YR