MAUDE Adverse Event Report: TEM INNOVATIONS GMBH EX-TEM® REAGENT; SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Catalog Number	503-05-US
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The risk review of the incident concluded that the harm associated with ffp transfusion includes allergic transfusion reactions, transfusion associated circulatory overload, and rarely transfusion related acute lung injury.These adverse reactions are temporary or reversible safety consequences to the patient.In conclusion, the root cause is unknown as the reagent was not returned for evaluation.No further action is required.All rotem delta reagents are shipped in controlled temperature and the instructions for use indicates that the rotem delta results should not be the sole basis for a patient diagnosis.The company will continue to monitor this issue.
Event or Problem Description
Customer reported seeing extended ex-tem ct's on their rotem delta instrument with patient result on new reagent lot.The customer reports that two patients were possibly inappropriately transfused fresh frozen plasma (ffp) due to erroneous ex-tem ct values.The customer did not report an adverse event from the transfusions.

• Brand Name: EX-TEM® REAGENT
• Common Device Name: SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES
• Manufacturer (Section D): TEM INNOVATIONS GMBH; 13 martin-kollar-strasse; munich, gm 81829 ; GM 81829
• MDR Report Key: 7625899
• Report Number: 3005792925-2018-00004
• Device Sequence Number: 176654
• Product Code: JPA
• UDI-Device Identifier: 04260160470242
• UDI-Public: 04260160470242
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K101533
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2018

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: No Information
• Device Expiration Date: 06/19/2018
• Device Catalogue Number: 503-05-US
• Device Lot Number: 21929008
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2018
• Initial Report FDA Received Date: 06/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1