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 2016-11-15 for CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE 04628918190 manufactured by Roche Diagnostics.
[59898753]
(b)(4). This event occurred in (b)(6). Expiration date was provided as "02/2018. "
Patient Sequence No: 1, Text Type: N, H10
[59898754]
The customer received questionable crphs cardiac c-reactive protein (latex) high sensitive results for one patient when dilutions were performed. The customer used a cobas 6000 c (501) module. The serial number of the analyzer was requested, but it was not provided. The undiluted result was 149. 32 mg/l with a data flag. With a 1:3 dilution, the result was 51. 86 mg/l with a data flag. With a 1:5 dilution, the result was 14. 66 mg/l with a data flag. With a 1:10 dilution, the result was 0. 00 mg/l. With a 1:20 dilution, the result was 0. 00 mg/l. With a 1:50 dilution, the result was 0. 00 mg/l. The sample was repeated on cobas 8000 c 702 module. The serial number of the analyzer was requested, but it was not provided. The undiluted result was 203. 41 mg/l with a data flag. With a 1:3 dilution, the result was 71. 51 mg/l with a data flag. With a 1:5 dilution, the result was 19. 07 mg/l. With a 1:10 dilution, the result was 0. 00 mg/l. With a 1:20 dilution, the result was 0. 00 mg/l. The result of 51. 68 mg/l was reported to the physician. The patient was not adversely affected. The customer had no problems with others assays or patient results.
Patient Sequence No: 1, Text Type: D, B5
[64747535]
A specific root cause could not be identified. Additional information for further investigation was requested but was not provided. A specific analyzer issue was not suspected as the issue occurred on multiple analyzers. The provided reaction monitors did not indicate any issues. Any interference from the patient's medication was excluded. An interference from a gammopathy was possible.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-01772 |
| MDR Report Key | 6102122 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-11-15 |
| Date of Report | 2017-01-11 |
| Date of Event | 2016-10-27 |
| Date Mfgr Received | 2016-10-27 |
| Date Added to Maude | 2016-11-15 |
| 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 | CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE |
| Generic Name | CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL |
| Product Code | NQD |
| Date Received | 2016-11-15 |
| Model Number | NA |
| Catalog Number | 04628918190 |
| Lot Number | 138687 |
| 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 | 2016-11-15 |