MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-06-21 for EX-TEM? REAGENT 503-05-US manufactured by Tem Innovations Gmbh.
[111982741]
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.
Patient Sequence No: 1, Text Type: N, H10
[111982742]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005792925-2018-00004 |
| MDR Report Key | 7625899 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-06-21 |
| Date of Report | 2018-06-21 |
| Date of Event | 2018-03-15 |
| Date Mfgr Received | 2018-03-15 |
| Device Manufacturer Date | 2017-10-12 |
| Date Added to Maude | 2018-06-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS THALIA CHARLES |
| Manufacturer Street | 13 MARTIN-KOLLAR-STRASSE |
| Manufacturer City | MUNICH, GM 81829 |
| Manufacturer Country | GM |
| Manufacturer Postal | 81829 |
| Manufacturer G1 | TEM INNOVATIONS GMBH |
| Manufacturer Street | 13 MARTIN-KOLLAR-STRASSE |
| Manufacturer City | MUNICH, GM 81829 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 81829 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EX-TEM? REAGENT |
| Generic Name | SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES |
| Product Code | JPA |
| Date Received | 2018-06-21 |
| Catalog Number | 503-05-US |
| Lot Number | 21929008 |
| Device Expiration Date | 2018-06-19 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TEM INNOVATIONS GMBH |
| Manufacturer Address | 13 MARTIN-KOLLAR-STRASSE MUNICH, GM 81829 GM 81829 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-21 |