MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH DADE INNOVIN; TEST, TIME, PROTHROMBIN

Model Number	N/A
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An outside of the united states (ous) customer contacted the siemens customer care center (ccc) to report discordant prothrombin time (pt) results with the dade innovin assay on a bft ii analyzer.Quality controls (qcs) recovered within ranges.Per the limitations section of the dade innovin instructions for use (ifu): "results of this test should always be interpreted in conjunction with the patient's medical history, clinical presentation and other findings." siemens is investigating.Note: the dade innovin assay is marketed in the united states under the material number 10873566.The 510(k) number documented in section g4 is for this product.
Event or Problem Description
The customer reported discordant prothrombin time (pt) results measured with the bft ii analyzer compared to the ca-500 system and about discrepancies of results within run on bft ii analyzer when sample was measured in two-fold determination.Only one specific patient (described as patient x) is affected.Erroneous results were not provided to the physician(s).The repeat results on the ca-500 system were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant prothrombin time results.
Additional Manufacturer Narrative
On 01-jul-2024.Additional information 02-jul-2024: siemens investigation assessed the issue as follows: reagent issues were ruled out based on review of quality controls (qc) which showed recovery within acceptable ranges and no issues were reported with other patient samples.Assessment of instrument performance included a review of testing on another analyzer.When tested on another bft ii analyzer with fresh reagents, the same discrepancy is observed.Based on the available information, the cause of the discordant result is consistent with a sample specific interferent.The customer is operational, and the reported issue is resolved by routine troubleshooting.The dade innovin lot 564610b is performing as intended.A product performance issue has not been identified.No further evaluation of the device is required.In section d4, the primary udi number was updated to include the corrected unique device identifier (udi) number.The initial mdr contained only the global trade item number (gtin).In section h6, the investigation findings and investigation conclusions codes were updated.

• Brand Name: DADE INNOVIN
• Common Device Name: TEST, TIME, PROTHROMBIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg 35041 ; GM 35041
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH; emil-von-behring- str. 76; marburg 35041 ; GM 35041
• Manufacturer Contact: karen confort ; 333 coney st.; east walpole, MA 02032 ; 3392069063
• MDR Report Key: 19648653
• Report Number: 9610806-2024-00013
• Device Sequence Number: 17781413
• Product Code: GJS
• UDI-Device Identifier: 00842768003790
• UDI-Public: (01)00842768003790(10)564610B(17)20250120
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K974343
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2024

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: 01/20/2025
• Device Model Number: N/A
• Device Catalogue Number: 10445705
• Device Lot Number: 564610B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 07/02/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Female