MAUDE Adverse Event Report: DADE ACTIN FSL APTT REAGENT

Model Number	DADE ACTIN FSL APTT REAGENT
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A united states (us) customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered low and out of range at the time when the discordant, falsely low aptt result was obtained.After the discordant result was obtained, the customer poured fresh dade actin fsl aptt reagent and reran qc.The qc then recovered in range.A siemens customer service engineer (cse) was dispatched to the customer site.The cse ran a precision study for aptt, which recovered acceptably.The cse also reran qc which recovered in range.The system was operational upon the cse's departure.Siemens is investigating the issue.
Event or Problem Description
A discordant, falsely low activated partial thromboplastin time (aptt) result was obtained on a patient sample on a sysmex ca-660 system using dade actin fsl aptt reagent.The discordant result was reported to the physician(s).The patient's heparin dose was adjusted due to the low aptt result.The sample was repeated three hours later for aptt, recovering higher.The higher result was reported, as the correct result, to the physician(s).Another sample from this patient had been tested earlier in the morning for aptt and had also recovered higher and been reported to the physician(s).Later that night, a new sample from the patient was drawn after the patient's heparin dose was adjusted.The sample was run for aptt, recovering higher.This result was also reported, as the correct result, to the physician(s).There are no known reports of adverse health consequences due to the discordant, falsely low activated partial thromboplastin time (aptt) or the change in heparin dose.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2021-00064 on 12-oct-2021.Additional information (15-oct-2021): the issue was isolated to one patient sample and no mechanical errors occurred at the time of the event.The precision study for activated partial thromboplastin time (aptt) recovered acceptably.Inadequate reagent handling, sample mixing, centrifugation or other mishandling of the sample cannot be ruled out as contributing factors to the event.The customer ran the affected patient sample and reported the discordant result when quality controls (qc) were out of range.The cause of the event is use error.The reagent is performing according to specifications.No further evaluation of this device is required.

• Brand Name: DADE ACTIN FSL APTT REAGENT
• Common Device Name: DADE ACTIN FSL APTT REAGENT
• MDR Report Key: 12615396
• Report Number: 9610806-2021-00064
• Device Sequence Number: 1348963
• Product Code: GGW
• UDI-Device Identifier: 00842768003882
• UDI-Public: 00842768003882
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K863594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2022
• Device Model Number: DADE ACTIN FSL APTT REAGENT
• Device Catalogue Number: 10445714
• Device Lot Number: 562615A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 41 YR