MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-11-22 for ROCHE ACETAMINOPHEN 20767174322 manufactured by Roche Diagnostics.
[20216245]
The customer reported failing an api survey for calcium and acetaminophen when the tests were run on the cobas c311 analyzer, serial number (b)(4). Of the results provided, four of the acetaminophen results were discrepant. For sample 1 the customer reported an acetaminophen of 67. 1 ug/ml to the survey; the expected range was 77. 2 - 95. 5 ug/ml. The test was repeated with an acetaminophen of 65. 1 ug/ml. After replacement with new reagent and calibration of the assay the customer obtained values of 81. 3 and 81. 8 ug/ml. For sample 2 the customer reported an acetaminophen of 23. 7 ug/ml to the survey; the expected range was 26. 8 - 34. 9 ug/ml. The test was repeated with an acetaminophen of 23. 4 ug/ml. After replacement with new reagent and calibration of the assay the customer obtained a value of 28. 8 ug/ml. For sample 3 the customer reported an acetaminophen of 44. 9 ug/ml to the survey; the expected range was 53. 8 - 84. 4 ug/ml. The test was repeated with an acetaminophen of 44. 2 ug/ml. After replacement with new reagent and calibration of the assay the customer obtained values of 55. 0 and 54. 7 ug/ml. For sample 4 the customer reported an acetaminophen of 28. 4 ug/ml to the survey; the expected range was 33. 6 - 42. 4 ug/ml. The test was repeated with an acetaminophen of 28. 9 ug/ml. After replacement with new reagent and calibration of the assay the customer obtained a value of 35. 0 ug/ml. There were no patients involved in the event, therefore none were adversely affected. Quality controls for acetaminophen were in range. The customer had last calibrated the assay in (b)(6). The customer stated that acetaminophen was not run very often and, "they did not have very many qc points to use for tracking or trending," and they believed that lead to running the survey on, "less than ideal reagent. " the customer declined a service visit.
Patient Sequence No: 1, Text Type: D, B5
[20582349]
.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2010-06898 |
| MDR Report Key | 1904243 |
| Report Source | 05,06 |
| Date Received | 2010-11-22 |
| Date of Report | 2010-11-22 |
| Date of Event | 2010-09-16 |
| Date Mfgr Received | 2010-10-25 |
| Date Added to Maude | 2011-04-07 |
| 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 ERIC KOLODZIEJ |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175212834 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68300 |
| Manufacturer Postal Code | 68300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROCHE ACETAMINOPHEN |
| Generic Name | COLORIMETRY, ACETAMINOPHEN |
| Product Code | LDP |
| Date Received | 2010-11-22 |
| Model Number | NA |
| Catalog Number | 20767174322 |
| Lot Number | 21110900 |
| ID Number | NA |
| Device Expiration Date | 2011-05-31 |
| 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 | 2010-11-22 |