MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH PATHROMTIN SL

Model Number PATHROMTIN SL

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

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

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and reported that different activated partial thromboplastin time (aptt) results were obtained when a patient sample was run on two different atellica coag 360 systems using pathromtin sl reagent.A siemens customer service engineer (cse) was dispatched to the customer site.The cse reviewed the error logs and found no indication of a hardware failure.The system data files were sent to siemens for further investigation.Quality controls (qc) recovered within range on both systems prior to and after the potentially discordant results were obtained.The system data indicated proper sample aspiration and delivery of sample to the cuvette.All measurement kinetics were evaluated correctly, and all aptt results show a usual coagulation reaction curve.The cause of the potentially discordant aptt results is unknown.Pre-analytical factors or a sample specific issue could not be ruled out.The reagent is performing according to specifications.No further evaluation of this device is required.

Event Description

A patient sample was run for activated partial thromboplastin time (aptt) on an atellica coag 360 system (serial number: (b)(4)) with pathromtin sl reagent (lot number: 536709d) and was then repeated for aptt on a second atellica coag 360 system (serial number: (b)(4)) with pathromtin sl reagent (lot number: 536709d), resulting lower.The sample was then repeated again for aptt on the first atellica coag 360 system (serial number: (b)(4)), resulting higher and matching the initial result obtained on that system.The sample was then repeated again for aptt on the second atellica coag 360 system (serial number: (b)(4)), resulting lower.None of the results were reported to the physician(s).It is unknown which aptt results are correct.A new sample from the same patient was then run for aptt several times on three atellica coag 360 systems (serial numbers: (b)(4)), resulting lower than the original results obtained on atellica coag 360 system (serial number: (b)(4)) and higher than the original results obtained on atellica coag 360 system (serial number: (b)(4)).It is unknown if these results are considered correct or if they were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant activated partial thromboplastin time results.

• Brand Name: PATHROMTIN SL
• Type of Device: PATHROMTIN SL
• 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: christopher aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145242740
• MDR Report Key: 8969327
• MDR Text Key: 159636623
• Report Number: 9610806-2019-00072
• Device Sequence Number: 1
• Product Code: GFO
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K955450
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2020
• Device Model Number: PATHROMTIN SL
• Device Catalogue Number: 10484200
• Device Lot Number: 536709D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2019
• 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: 56 YR
• Patient Weight: 130