MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-01-24 for ROCHE CARDIAC TROP T 07007302190 manufactured by Roche Diagnostics.
[134081897]
The event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[134081898]
The customer received questionable roche cardiac poc troponin t results from a cobas h232 meter serial number (b)(4). The cobas h232 meter is not approved for distribution nor is like or similar to a product approved for distribution in the united states. The customer tested 4 different heparinized blood samples from a patient that presented with suspected coronary syndrome on a cobas h232 and compared the results to the troponin t high sensitivity results from a cobas 6000 e 601 module. Sample a troponin t result from the cobas h232 was 583 pg/ml with a data flag. The troponin t result from the cobas e602 was 3. 1 pg/ml. Sample b troponin t result from the cobas h232 was 663 pg/ml with a data flag. The troponin t result from the cobas e602 was < 3 pg/ml. Sample c troponin t result from the cobas h232 was 1033 pg/ml with a data flag. The troponin t result from the cobas e602 was < 3 pg/ml. Sample d troponin t result from the cobas h232 was 715 pg/ml with a data flag. The troponin t result from the cobas e602 was 3. 5 pg/ml. The erroneous results were reported outside of the laboratory. According to the customer, based on the electrocardiogram (ecg) testing and the ck and ck-mb data obtained, the data did not fit an acute infarction diagnosis. The emergency room physician administered heparin, morphine, aspirin, vomex, sterofundin, and nitro lingual spray. The customer stated this is standard therapy that they give to anyone suspected of having a heart attack. There was no information provided to reasonably suggest that the patient was adversely affected by the treatment. Clarification has been requested. The patient stated that they have been healthy and only recently taken an unspecified antibiotic. Qc results were acceptable. The cobas h232 and the troponin test strips have been requested for return. The investigation is currently ongoing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-00262 |
| MDR Report Key | 8274972 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-01-24 |
| Date of Report | 2019-03-15 |
| Date of Event | 2019-01-06 |
| Date Mfgr Received | 2019-01-07 |
| Date Added to Maude | 2019-01-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175214343 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROCHE CARDIAC TROP T |
| Generic Name | IMMUNOASSAY METHOD, TROPONIN SUBUNIT |
| Product Code | MMI |
| Date Received | 2019-01-24 |
| Model Number | NA |
| Catalog Number | 07007302190 |
| Lot Number | 35654411 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-24 |