MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH INNOVANCE D-DIMER

Model Number INNOVANCE D-DIMER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

The patient sample has been checked for hemolysis, icterus, lipemia and micro-clots and no issues were observed.The customer indicated that they were not able to retest the patient for d-dimer because they were not able to contact the patient to obtain a new sample.The cause of the issue is unknown.The innovance d-dimer reagent with catalog number 10445980 described is not marketed in the united states (us) and the pma/510(k) number is for the us specific reagents.The innovance d-dimer reagents marketed in the us have catalog numbers 10445981 and 10445982.

Event Description

A false negative d-dimer result was obtained on a patient sample on the sysmex cs-2100i instrument.The false negative result was reported to the physician, who questioned the result.It is unknown whether any medical procedure or treatment was performed due to the false negative result.The following day, the same patient sample was rerun, in duplicate, on an alternate sysmex cs-2100i instrument and the original instrument.The sample was repeated with a 1:8 dilution on both instruments, resulting higher.It is unknown whether a corrected report was provided to the physician.There are no known reports of patient intervention or adverse health consequences due to the false negative d-dimer result.

Manufacturer Narrative

Siemens healthcare diagnostics inc.(siemens) filed the initial mdr 9610806-2017-00093 on august 28, 2017.Additional information ((b)(6) 2017): on (b)(6) 2017, siemens field service engineer (fse) was dispatched to the customer's site to determine the cause of the false negative d-dimer result on the sysmex cs-2100i instrument and found no issues.The fse performed a preventative maintenance on the instrument and replaced and realigned the sample probes and reagent probes.Additional information ((b)(6) 2017): the customer indicated they have not encountered any issues on the instrument since the fse was dispatched to the site.The cause of the false negative d-dimer result is unknown.The instrument is performing according to specifications.No further evaluation of this instrument is required.

• Brand Name: INNOVANCE D-DIMER
• Type of Device: INNOVANCE D-DIMER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• Manufacturer Contact: christina lam ; 511 benedict ave; tarrytown, NY 10591 ; 9145243504
• MDR Report Key: 6823898
• MDR Text Key: 83863205
• Report Number: 9610806-2017-00093
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/26/2017

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: 08/28/2018
• Device Model Number: INNOVANCE D-DIMER
• Device Catalogue Number: 10445980 (SEE SECTION H10)
• Device Lot Number: 46678
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/28/2017
• Supplement Dates Manufacturer Received: 08/07/2017
• Supplement Dates FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 50 YR