MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH DADE ACTIN FSL ACTIVATED PTT REAGENT

Model Number DADE ACTIN FSL ACTIVATED PTT REAGENT

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

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

Event Date 09/19/2018

Event Type  malfunction  

Manufacturer Narrative

A customer contacted a siemens customer care center (ccc) and indicated that they obtained discordant activated partial thromboplastin time (aptt) results on a patient sample using the dade actin fsl activated ptt reagent.As per siemens' instructions, the customer performed a precision study using quality controls, resulting acceptably.Siemens investigated the instrument files and observed that the samples were flagged with err 128 (early reaction error) and err 004 (analysis time over).The sysmex ca-1500 system advises customers that an abnormal reaction was detected at the initial stage of the coagulation because of a reagent problem and to check the coagulation curve, increase the maximum detection time and check the status of the sample and reagent for re-analysis when these errors are triggered during sample analysis.Quality controls (qcs) recovered within lab ranges on the day of the event.The customer suspected that the samples were contaminated.Siemens further investigated the event and determined that there were no mechanical or analysis errors, indicating there were no system malfunctions.Siemens concluded that the cause of the discordant, falsely low aptt result was sample specific and was potentially caused by pre-analytical factors.The system and reagent are performing according to specifications.No further evaluation of these devices is required.Mdr 9610806-2018-00104 was filed for the same issue.

Event Description

A flagged, elevated activated partial thromboplastin time (aptt) result was obtained on a patient sample using the dade actin fsl activated ptt reagent on a sysmex ca-1500 system.The sample was repeated on an alternate sysmex ca-1500 system using the same reagent lot, resulting in another elevated aptt result.The sample was repeated on the initial system and a discordant, falsely low result was obtained.The sample was repeated twice on the alternate system, resulting in flagged, elevated aptt results.The customer reported the aptt result of >200 seconds, as the correct result, to the physician(s).The patient was redrawn and the new sample was run on one of the systems; a result of >200 seconds was obtained on the re-drawn sample.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low aptt results.

• Brand Name: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Type of Device: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT GMBH; emil-von-behring-str 76; marburg, D-350 41; GM D-35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCT 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: 7962392
• MDR Text Key: 125143751
• Report Number: 9610806-2018-00105
• Device Sequence Number: 1
• Product Code: GGW
• UDI-Device Identifier: 00842768003882
• UDI-Public: 00842768003882
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K863594
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2019
• Device Model Number: DADE ACTIN FSL ACTIVATED PTT REAGENT
• Device Catalogue Number: 10445714
• Device Lot Number: 556922A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/11/2017
• 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