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 10/23/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they received questionable results for three patient samples tested with d-di tina-quant d-dimer gen.2 on a cobas 8000 c 502 module.The customer stated that the samples will initially be slightly below the technical limit of the assay, but when repeated with decreased sample volume, the results are much higher.The customer provided data for one of the affected patient samples and this sample had an erroneous d-di value.The erroneous result was not reported outside of the laboratory.The sample initially resulted with a value of 7704 ug/l.The sample was repeated using a decreased sample volume, resulting as 14857 ug/l.The sample was manually diluted x 2 and tested, resulting as 13322 ug/l.The sample was manually diluted x 3 and tested, resulting as 15657 ug/l.The sample was manually diluted x 4 and tested, resulting as 16474 ug/l.The sample was manually diluted x 5 and tested, resulting as 17300 ug/l.The sample was manually diluted x 6 and tested, resulting as 17322 ug/l.The sample was repeated on a siemens cs2500 module, resulting as 14148 ug/l.The sample was repeated on the c 502 analyzer on (b)(6) 2018, resulting as 7792 ug/l.The sample was repeated on the c 502 analyzer on (b)(6) 2018 using a decreased sample volume, resulting as 13991 ug/l.No adverse events were alleged to have occurred with the patient.The c502 analyzer serial number is (b)(4).

Manufacturer Narrative

The customer provided additional patient data.A second sample from the originally reported patient (designated as patient "b") also resulted with an erroneous initial d-dimer value.In addition, 10 samples from a second patient (designated as patient "a") also had erroneous initial d-dimer values.Refer to the attachment for all patient data.The initial values and the decreased sample volume values were reported outside of the laboratory to a doctor.The patients were not treated incorrectly based on the initial values.No adverse events were alleged to have occurred with the patients.(b)(6).

Manufacturer Narrative

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

Manufacturer Narrative

The investigation was able to reproduce the customer¿s results.One sample of patient a was investigated for an interfering factor.The results were within expected values and there were no hints to an interfering factor.Sample 15 of patient b was investigated for an interfering factor.The results were above the expected values.An interfering factor in this sample could not be excluded.The investigation is ongoing.

Manufacturer Narrative

The alarm trace contains multiple alarms including sample shortage, abnormal aspiration, and c.Stop alarms on the day of the event.The provided qc data shows great deviations between the different qc runs.The investigation is ongoing.

Manufacturer Narrative

Medwatch fields other relevant history and concomitant medical products were updated.

• 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: 8085292
• MDR Text Key: 129197909
• Report Number: 1823260-2018-04376
• 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,Followup,Followup,Followup
• Report Date: 03/19/2019

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 Expiration Date: 08/31/2019
• Device Catalogue Number: 04912551190
• Device Lot Number: 343317
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/01/2018
• Initial Date FDA Received: 11/19/2018
• Supplement Dates Manufacturer Received: 11/01/2018; 11/01/2018; 11/01/2018; 11/01/2018; 11/01/2018
• Supplement Dates FDA Received: 11/21/2018; 12/10/2018; 01/03/2019; 02/06/2019; 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BISACODYL ZETPIL (PATIENT B); GLUCOSE 5% INFUUS (PATIENT B); GLUCOSE/NATRIUMCHLORIDE 2.5%/0.45% (PATIENT B); HEPARINE (PATIENT A); HEPARINE IN NATRIUMCHLORIDE 0.9% (PATIENT B); KALIUMCHLORIDE (PATIENT B); MACROGOL/ELEKTROLYTEN NATUREL (PATIENT B); MIDAZOLAM (PATIENT B); MORFINE IN GLUCOSE 5% (PATIENT B); NATRIUMCHLORIDE 0.9% (PATIENT B); NORADRENALINE IN GLUCOSE 5% (PATIENT B); NUTRISON PROTEIN PLUS MULTI FIBER (PATIENT B); PANTOPRAZOL IV BOLUSINJECTIE (PATIENT B); PARACETAMOL TABLET (PATIENT B); PREDNISOLON (PATIENT B); PROPOFOL 2% (PATIENT B); RINGERLACTAT BOLUS (PATIENT B); SDD (DMB) (PATIENT B); SDD SUSPENSION (PATIENT B)
• Patient Age: 45 YR