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

Catalog Number OPBP07

Device Problem False Negative Result (1225)

Patient Problem Death (1802)

Event Date 02/01/2013

Event Type  malfunction  

Event Description

The hospital reported that discordant low, negative d-dimer results were reported on a patient's samples on two consecutive days.The patient results were reported to the physician.A positive d-dimer result had previously been obtained on an alternate methodology and the initial runs of the patient's samples were flagged as antigen excess on the siemens methodology, innovance(r) d-dimer.Upon repeats performed on the samples, the lab personnel sent out low, negative results based on their interpretation of the results on both days.The hospital alleges that patient treatment was altered on the basis of the falsely negative reported results and that no further confirmatory tests were performed.The hospital alleges that the lack of anticoagulant treatment contributed to the adverse outcome to the patient who expired on the third day as a result of the falsely negative d-dimer results.

Manufacturer Narrative

The cause of the reporting of discordant, negative d-dimer results is unknown.It is known that the initial results obtained with the siemens innovance(r) d-dimer test were flagged indicating antigen excess.It is at present unclear if proper reflex testing of a dilution of the sample was done as should be when antigen excess is flagged.The results were reported out as 0.1 mg/l.Based on siemens investigation to date, we are not aware of any malfunction associated with the innovance(r) d-dimer product.Siemens healthcare diagnostics is continuing to investigate the issue with the customer.Siemens will provide an update to this report when additional information becomes available.

Manufacturer Narrative

Siemens healthcare diagnostics inc.Filed the initial mdr (9610806-2014-00013) on february 18, 2014.Siemens communicated to customers that a flagged, non-numerical result has arbitrarily and erroneously been reported as a numerical low d-dimer value by a customer leading to an incident.The communication was issued to re-emphasize previous information that the sysmex cs-analyzers may give an antigen excess flag for patient samples tested with innovance® d-dimer reagent that contain a very high quantity of d-dimer.However, in rare cases, this flag may also occur for samples containing very low or no quantity of d-dimer.The communication emphasized that to corroborate the initial antigen excess-flagged result, a re-analysis is needed as defined in the user's manual.In the original application, the re-analysis of a 1/19 dilution for antigen excess flagged samples will be performed automatically if samples are measured in normal mode and both assay parameters "inn ddi~dod" and "inn ddi" are selected.These parameter settings are default settings and siemens healthcare diagnostics strongly recommends not deselecting or modifying any of them.If the aforementioned settings are not used, manual re-analysis has to be performed according to the instructions of the user manual.Antigen excess flagged results must under no circumstances be reported without re-analysis! siemens issued a customer notification br-02914 dated april 2014 to outside us customers identified as using a sysmex cs-2000i, cs-2100i, or cs-5100 analyzer in their laboratory and using innovance® d-dimer reagent.The analyzers were not cleared for sale in the u.S.We consider this case as being closed for the following reasons: based on our investigation, we are not aware of any malfunction associated with neither the instrument nor the innovance® d-dimer product and we are not aware of similar cases.

• Brand Name: INNOVANCE(R) D-DIMER
• Type of Device: INNOVANCE(R) D-DIMER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; 76 emil von behring strasse; marburg, 35041 ; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; 76 emil von behring strasse; marburg, 35041 ; GM 35041
• Manufacturer Contact: james morgera ; glasgow business community; po box 6101; newark, DE 19714-6101 ; 3026318356
• MDR Report Key: 3632983
• MDR Text Key: 3984568
• Report Number: 9610806-2014-00013
• Device Sequence Number: 1
• Product Code: DAP
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K093626
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Medical Technologist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 10/14/2015
• Device Catalogue Number: OPBP07
• Device Lot Number: 43435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2014
• Initial Date FDA Received: 02/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 25 YR