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

Catalog Number 04877802190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received questionable results for 5 patient samples tested with roche cardiac d-dimer and roche cardiac probnp+ on a cobas h 232 analyzer.Of the 5 samples, two had erroneous d-dimer results.The cobas h 232 analyzer is not released for distribution in the united states, nor is it like or similar to a product released for distribution in the united states.The first sample initially resulted with a d-dimer value of 2.13 ug/ml when tested on the customer's cobas h 232 analyzer.The sample was sent to another laboratory for testing with an unknown method, resulting with a d-dimer value of 3.65 ug/ml.The second sample initially resulted with a d-dimer value of 0.52 ug/ml when tested on the customer's cobas h 232 analyzer.The sample was sent to another laboratory for testing with an unknown method, resulting with a d-dimer value of 0.76 ug/ml.No adverse events were alleged to have occurred with the patients.The cobas h 232 analyzer serial number is (b)(4).Controls were tested on the analyzer and these passed.

Manufacturer Narrative

Material was requested for investigation, but not provided.No investigation could be performed, as no material was available.The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

The customer's cobas h 232 meter was provided for investigation.The meter could not be used for testing due to reaching the maximum amount of tests.The customer¿s cobas h232 meter had the strip counter reset to zero in order to perform further testing for the investigation.Relevant retention material roche cardiac d-dimer of lot 34431310 was measured on the customer¿s cobas h 232 meter (after test strip counter reset) in comparison to a qualified cobas h232 with one spiked blood sample (c=1.1 g/ml).The sample was measured three times on each meter.Testing was carried out with relevant retention material roche cardiac d-dimer of lot 34431310 (dd3131) and measured on a qualified cobas h 232 with three spiked blood samples (c=0.65 ¿g/ml, c=2.2 g/ml and c=3.5 g/mlg/ml), in comparison with the master lot #17339780.Each sample was tested three times with each test strip lot.Mean of the measurements on qualified cobas h232 with relevant retention material # 34431310: first spiked blood sample (c=0.65 g/ml): 0.57 g/ml, second spiked blood sample (c=2.2 g/ml): 1.92 g/ml, third spiked blood sample (c=3.5 g/ml): 3.77 g/ml.Mean of the measurements on qualified cobas h232 with master lot: first spiked blood sample (c=0.65 g/ml): 0.59 g/ml, second spiked blood sample (c=2.2 g/ml): 1.89 g/ml, third spiked blood sample (c=3.5 g/ml): 3.85 g/ml.The measurements results with relevant retention material and master lot on a qualified cobas h232 fulfill roche requirements.Mean of the measurements with relevant retention material of d-dimer lot 34431310 on the customer¿s cobas h232: 1.12 g/ml.Mean of the measurements with relevant retention material of d-dimer lot 34431310 on a qualified cobas h232: 1.61 g/ml.The measurements confirm lower values with the customer¿s cobas h232 in comparison to a qualified cobas h232.The customer¿s cobas h232 meter was decontaminated and visually investigated.The error log was read-out.Internal quality control tests were performed.The customer¿s cobas h232 meter was also opened and the measuring module was investigated for contamination.The internal quality tests performed on the customer¿s cobas h232 meter passed.The investigation of the opened customer's cobas h232 identified a dirty mirror.The type of contamination led to the conclusion that the issue was caused by improper handling of the meter.

Manufacturer Narrative

The unknown method at the other laboratory was confirmed to be d-dimer on a second cobas h 232 analyzer.

• Brand Name: ROCHE CARDIAC D-DIMER
• Type of Device: FIBRINOGEN AND FIBRIN SPLIT PRODUCTS
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8316348
• MDR Text Key: 135504623
• Report Number: 1823260-2019-00505
• Device Sequence Number: 1
• Product Code: GHH
• Combination Product (y/n): N
• PMA/PMN Number: K033491
• 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,Followup
• Report Date: 08/19/2019

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 Catalogue Number: 04877802190
• Device Lot Number: 34431310
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/07/2019
• Supplement Dates Manufacturer Received: 01/23/2019; 01/23/2019; 01/23/2019
• Supplement Dates FDA Received: 03/19/2019; 06/17/2019; 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1