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

Model Number DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered low and out of range since (b)(6) 2020, but patient results were still reported.It is unknown if qc recovered in range from (b)(6) 2020 through (b)(6) 2020.Siemens is investigating the issue.Mdrs 9610806-2021-00010, 9610806-2021-00011, 9610806-2021-00012, 9610806-2021-00013, 9610806-2021-00014, 9610806-2021-00016 were filed for discordant results obtained on (b)(6) 2020, (b)(6) 2020, (b)(6) 2020, (b)(6) 2020, (b)(6) 2020, and (b)(6) 2020, respectively.

Event Description

Discordant, falsely low activated partial thromboplastin time (aptt) results were obtained on multiple patient samples between (b)(6) 2020 and (b)(6) 2020 on a bcs xp system using dade actin activated cephaloplastin reagent.The discordant results were reported to the physician(s).The samples were repeated for aptt on the same bcs xp system using pathromtin sl reagent, recovering higher.The higher results were reported, as the correct results, to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low activated partial thromboplastin time (aptt) results.

Manufacturer Narrative

Siemens filed the initial mdr 9610806-2021-00015 on (b)(6) 2021.Additional information (21-jan-2021): siemens investigated the short recovery of quality controls (qc) with dade actin activated cephaloplastin reagent reported by the customer.The investigation concluded that qc recovered acceptably in range.Reagent handling issues cannot be ruled out as a potential cause of the customer's out of range qc results, as the customer's qc recovery varied day by day.Differences in activated partial thromboplastin time (aptt) results are expected when using different aptt reagents, as each reagent has its own reference range.The patient results obtained with dade actin activated cephaloplastin reagent and the results obtained with pathromtin sl reagent compare well with each other, as the results recovered either both short or both prolonged.However, the customer reported patient results when qc recovered out of range.The cause of the event is a use error.The reagent is performing according to specification.No further evaluation of this device is required.Supplemental mdrs 9610806-2021-00010_s1, 9610806-2021-00011_s1, 9610806-2021-00012_s1, 9610806-2021-00013_s1, 9610806-2021-00014_s1, and 9610806-2021-00016_s1 were also filed for the additional information obtained on (b)(6) 2021.

• Brand Name: DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT
• Type of Device: DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring-str. 76; marburg, D-350 41; GM D-35041
• MDR Report Key: 11187896
• MDR Text Key: 256673363
• Report Number: 9610806-2021-00015
• Device Sequence Number: 1
• Product Code: GFO
• UDI-Device Identifier: 00842768003851
• UDI-Public: 00842768003851
• Combination Product (y/n): N
• PMA/PMN Number: K760318
• 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: 02/15/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2021
• Device Model Number: DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT
• Device Catalogue Number: 10445711
• Device Lot Number: 557609
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/18/2021
• Supplement Dates Manufacturer Received: 01/21/2021
• Supplement Dates FDA Received: 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1