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

Model Number	DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted a siemens customer care center (ccc).Quality controls (qc) recovered low and out of range since 21-dec-2020, but patient results were still reported.It is unknown if qc recovered in range from 14-dec-2020 through 20-dec-2020.Siemens is investigating the issue.Mdrs 9610806-2021-00010, 9610806-2021-00012, 9610806-2021-00013, 9610806-2021-00014, 9610806-2021-00015, 9610806-2021-00016 were filed for discordant results obtained on 14-dec-2020, 17-dec-2020, 18-dec-2020, 21-dec-2020, 22-dec-2020, and 23-dec-2020, respectively.
Event or Problem 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 cephalostatin 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.
Additional Manufacturer Narrative
Siemens filed the initial mdr 9610806-2021-00011 on 18-jan-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, 9610806-2021-00012_s1, 9610806-2021-00013_s1, 9610806-2021-00014_s1, 9610806-2021-00015_s1, and 9610806-2021-00016_s1 were also filed for the additional information obtained on 21-jan-2021.

• Brand Name: DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT
• Common Device Name: 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: 11187905
• Report Number: 9610806-2021-00011
• Device Sequence Number: 19745040
• Product Code: GFO
• UDI-Device Identifier: 00842768003851
• UDI-Public: 00842768003851
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K760318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 01/22/2021
• Device Model Number: DADE ACTIN ACTIVATED CEPHALOPLASTIN REAGENT
• Device Catalogue Number: 10445711
• Device Lot Number: 557602
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/23/2020
• Supplement Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 01/18/2021
• Supplement Report FDA Received Date: 02/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1