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 2018-04-17 for CRPL3 C-REACTIVE PROTEIN GEN.3 05172373190 manufactured by Roche Diagnostics.
[105769873]
(b)(4). This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[105769874]
The customer consistently received low crpl3 c-reactive protein gen. 3 results for one patient that did not match the clinical picture which strongly suggested elevated crp levels should be present. The patient was in the intensive ward and was admitted (b)(6) 2018 after acute onset of retrosternal chest pain with no obvious signs of ischemia. The patient's troponin-i results were 246 ng/l and 1878 ng/l. The patient was given double platelet inhibition+ fondaparinux and was transferred to another hospital. A coronary angiography was performed and it was decided to do an acb (aorta coronar bypass) operation on (b)(6) 2018. The reason for operation was "nstemi with need for surgical revasculation". The patient had the flu around (b)(6) and the operation was postponed, but was successfully performed (b)(6) 2018. During the patient's stay in the hospital, there was no increase in crp, not even after the operation nor during the period the patient had the flu. Results provided for multiple samples from (b)(6) 2018 through (b)(6)2018 were all <1 mg/l. On 24-mar-2018, crp was measured on an affinion point of care device and no crp was detected. The results were reported outside of the laboratory. There was no allegation of an adverse event. The customer used cobas 8000 c 702 module serial number (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01179 |
| MDR Report Key | 7435574 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-17 |
| Date of Report | 2018-06-04 |
| Date of Event | 2018-03-06 |
| Date Mfgr Received | 2018-04-03 |
| Date Added to Maude | 2018-04-17 |
| 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 | 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 | CRPL3 C-REACTIVE PROTEIN GEN.3 |
| Generic Name | C-REACTIVE PROTEIN IMMUNOLOGICAL TEST SYSTEM |
| Product Code | DCN |
| Date Received | 2018-04-17 |
| Model Number | NA |
| Catalog Number | 05172373190 |
| Lot Number | 111111 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-04-17 |