MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-10-20 for C-REACTIVE PROTEIN GEN.3 04956842190 manufactured by Roche Diagnostics.
[5020643]
The customer reported that they received questionable results for eight different samples from the same patient tested for c-reactive protein gen. 3 (crp). The patient's physician was concerned because the crp results were considered to be negative, but blood cultures for this patient were positive. The crp values from all eight samples were questioned by the physician. Samples were tested on 2 different c501 modules. This medwatch is for reagent lot 68994601 with an expiration date of 01/31/2015 and used on c501 serial number (b)(4). The first sample resulted as 2. 0 mg/l on c501 module serial number (b)(4). The second sample, tested on (b)(6) 2014, resulted as 1. 9 mg/l on c501 module serial number (b)(4). The third sample, tested on (b)(6) 2014, resulted as 2. 8 mg/l on c501 module serial number (b)(4). The fourth sample, tested on (b)(6) 2014, resulted as 0. 1 mg/l on c501 module serial number (b)(4). The fifth sample, tested on (b)(6) 2014, resulted as 0. 2 mg/l on c501 module serial number (b)(4). The sixth sample, tested on (b)(6) 2014, resulted as 1. 2 mg/l on c501 module serial number (b)(4). The seventh sample, tested on (b)(6) 2014, resulted as 0. 9 mg/l on c501 module serial number (b)(4). The eighth sample, tested on (b)(6) 2014, resulted as 1. 1 mg/l on c501 module serial number (b)(4). The patient had two blood culture samples that were drawn at the same time on (b)(6) 2014. One blood culture sample was a line draw and the other sample was a phlebotomy draw. The final results for both cultures yielded staphylococcus epidermidis. The physician treated the patient with vancomycin since he did not believe the crp results. The patient is still in the hospital since it was a premature newborn. There was a subsequent negative blood culture result on (b)(6) 2014, but the patient is still on vancomycin. The patient was not adversely affected. The customer declined a service visit.
Patient Sequence No: 1, Text Type: D, B5
[12492241]
It was unknown if the initial reporter sent report to the fda. Reference the medwatch with patient identifier (b)(6) for additional data related to this event.
Patient Sequence No: 1, Text Type: N, H10
[12604960]
A specific root cause could not be determined based on information provided. Additional information for further investigation was requested but not provided. The customer stated that samples were run in micro cups, but does not know if the samples had been programmed specifically as micro cup samples. If the samples were not programmed as micro cup samples, this could have been the cause of the issue as sample pipetting may be inaccurate if not selected, which could lead to inaccurate measurements.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-08066 |
| MDR Report Key | 4186156 |
| Report Source | 05,06 |
| Date Received | 2014-10-20 |
| Date of Report | 2014-11-04 |
| Date of Event | 2014-09-16 |
| Date Mfgr Received | 2014-09-26 |
| Date Added to Maude | 2014-10-20 |
| 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 | 0 |
| 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 | C-REACTIVE PROTEIN GEN.3 |
| Generic Name | SYSTEM, TEST, C-REACTIVE PROTEIN |
| Product Code | DCN |
| Date Received | 2014-10-20 |
| Model Number | NA |
| Catalog Number | 04956842190 |
| Lot Number | 68994601 |
| ID Number | NA |
| Device Expiration Date | 2015-01-31 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-20 |