MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-07-17 for CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE 04628918190 manufactured by Roche Diagnostics.
[80386752]
Unique identifier (udi)#: (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[80386753]
The customer stated that they have had issues with results for an unspecified number of patient samples tested with the crphs cardiac c-reactive protein (latex) high sensitive (crphs) assay ever since installation of the cobas 6000 c (501) module - c501 on approximately (b)(6)2017. The customer provided data for four patient samples which had erroneous initial results that were reported outside of the laboratory. The samples were repeated on the same analyzer and the repeat results were believed to be correct. The first sample initially resulted as 2. 93 mg/l and repeated as 4. 83 mg/l. The second sample, from a (b)(6) year old female, initially resulted as 5. 85 mg/l and repeated as 8. 52 mg/l. The third sample, from a (b)(6) year old male, initially resulted as 3. 04 mg/l and repeated as 5. 66 mg/l. The fourth sample, from a (b)(6) year old male, initially resulted as 2. 94 mg/l and repeated as 4. 68 mg/l. No adverse events were alleged to have occurred with the patients. The c501 analyzer serial number was (b)(4). To resolve the issue, the customer replaced the reagent pack and calibrated a new reagent pack of a new lot. The reagent pack that was in use during the time of the issue had been in use for 6 months and had calibration issues. The stability of an opened reagent pack is 12 weeks. The customer calibrated and ran quality controls on a new reagent pack; these were ok. Precision studies were performed and these were ok. The field service engineer ran mechanism checks and these were ok. He checked the gear pump and vacuum; these were ok.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01472 |
| MDR Report Key | 6719419 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-07-17 |
| Date of Report | 2017-08-13 |
| Date of Event | 2017-06-28 |
| Date Mfgr Received | 2017-06-28 |
| Date Added to Maude | 2017-07-17 |
| 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 |
| 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 | CRPHS CARDIAC C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE |
| Generic Name | CARDIAC C-REACTIVE PROTEIN, ANTIGEN, ANTISERUM, AND CONTROL |
| Product Code | NQD |
| Date Received | 2017-07-17 |
| 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 | 2017-07-17 |