MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE ACTIN FS ACTIVATED PTT REAGENT

Model Number DADE ACTIN FS ACTIVATED PTT REAGENT

Device Problem High Test Results (2457)

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

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

The customer contacted siemens customer care center and reported that a discordant, falsely elevated activated partial thromboplastin time (aptt) result was obtained using the dade actin fs activated ptt reagent from lot 538524.The customer reported that they observed flocculation in the reagent vials and that quality controls (qcs) were within expected ranges on the day of the event.The customer provided an affected reagent vial and an unaffected reagent vial for further investigation.Siemens ran a study using internal dade actin fs activated ptt reagent vials from lot 538524 and the reagent vials provided by the customer.Siemens determined that qcs recovered within table of assigned values (tavs) ranges using the customer's vial without flocculation and outside of tavs ranges using the customer's vials with flocculation.Five normal patient samples and fresh frozen plasma were also tested for aptt using these vials; the results obtained using unaffected reagent vial provided by the customer and the internal reagent vials recovered as expected.The results obtained using the affected reagent vial recovered higher than expected.Siemens investigated the log files and determined that the affected reagent vial was changed directly before the discordant result was obtained.The customer reported that they switched to another dade actin fs activated ptt reagent lot 538546.The cause of the event is unknown.No further evaluation of this device is required.The rilibäk compliant dade actin fs activated ptt reagent with catalog number 10284498 described is not marketed in the united states (us) and the pma/510(k) number is for the us specific dade actin fs activated ptt reagents.The dade actin fs activated ptt reagent lots marketed in the us have catalog numbers 10445712 and 10445710.

Event Description

A discordant, falsely elevated activated partial thromboplastin time (aptt) result was obtained on a patient sample using the dade actin fs activated ptt reagent from lot 538524 on the sysmex cs-2500 system.The discordant result was reported to the physician(s), who questioned the result.The same sample was rerun twice, using another vial of dade actin fs activated ptt reagent from lot 538524, and expected results were obtained.The result obtained using the alternate reagent vial was reported, as the correct result, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated aptt result.

Manufacturer Narrative

Additional information (16-may-2018): siemens further investigated the cause of the event and determined that the customer did not run quality controls with the affected reagent vial.As per the dade actin fs activated ptt reagent's instruction for use (ifu), "two controls (one in the normal range and one in the pathological/therapeutical range) must be measured at the start of the test run, after each change of reagent vial, and at least once during an 8-hour shift.If the control values are outside of the confidence interval, the controls, reagents and instrument must be checked." siemens determined that the quality control recovery, using the affected vial, would have potentially recovered out of expected ranges, invalidating the discordant results obtained.Additionally, siemens inspected 21 reagent vials that have been stored at our manufacturing site and did not observe flocculation in any of these vials.Siemens concluded that the cause of the event was potentially contributed to a storage issue or was isolated to a single shipment.

• Brand Name: DADE ACTIN FS ACTIVATED PTT REAGENT
• Type of Device: DADE ACTIN FS ACTIVATED PTT REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 7508851
• MDR Text Key: 108161305
• Report Number: 9610806-2018-00047
• Device Sequence Number: 1
• Product Code: GGW
• Combination Product (y/n): N
• PMA/PMN Number: K811589
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2019
• Device Model Number: DADE ACTIN FS ACTIVATED PTT REAGENT
• Device Catalogue Number: 10284498 (SEE SECTION H10)
• Device Lot Number: 538524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1