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 2016-06-21 for CEDIA(R) CARBAMAZEPINE ASSAY 04874625190 manufactured by Roche Diagnostics.
[47843066]
Patient Sequence No: 1, Text Type: N, H10
[47843067]
The customer stated that their controls for the carbamazepine (carb) assay had shifted from low to high on the c501 analyzer. The customer also stated that two patient samples had questionable results for carb. Of the two samples, one had erroneous results. The sample initially resulted as 7. 1 ug/ml and this value was reported outside of the laboratory. The customer was concerned that the initial result may not be accurate, so the sample was repeated on a second c501 analyzer on (b)(6) 2016, resulting as 8. 7 ug/ml. The sample was also repeated on the original c501 analyzer on (b)(6) 2016, resulting as 10. 61 ug/ml. The customer did not know which result was correct, but did not issue a corrected report for the reported value of 7. 1 ug/ml since all 3 values were within the therapeutic range. The patient was not adversely affected. The original c501 analyzer serial number was (b)(4) and the second c501 analyzer serial number was (b)(4). The customer performed maintenance on the analyzer and repeated calibration and controls. Calibration passed and control recovery was better. The controls were within range and acceptable to the customer. The field service representative checked c501 analyzer serial number (b)(4) and was not able to determine a cause. He replaced syringe seals as a precaution. He checked rinse mechanism volumes, reagent probe volumes, photometer readings, and cuvette mixing. He performed precision studies. The field application specialist determined that both analyzers show the same pattern in fluctuation of control recovery. She determined that the stability of the assay was poor. A new lot of reagent was placed on the analyzer and calibrated with no alarms. Controls were tested and were within range. She provided the customer suggestions for calibration frequency and reagent handling.
Patient Sequence No: 1, Text Type: D, B5
[50204867]
It has been clarified that the correct serial numbers of the used c501 analyzers are as follows: the original c501 analyzer serial number was (b)(4) and the second c501 analyzer serial number was (b)(4). The customer also noted that they continue to have issues with the carb assay. When they load a new cassette, the pack calibration is successful, but the controls jump high on the new cassette. After two days on board the analyzer, the control recovery on the cassette returns to previous levels.
Patient Sequence No: 1, Text Type: N, H10
[50859839]
During investigations, it was recommended for the field service representative to perform the following items: exchange the gear pump head and confirm the correct pressure adjustment, perform maintenance on the analyzer, check the vacuum system, readjust all probes and cell rinse mechanisms, check for correct lamp voltage, check the reaction bath filter, check the reaction bath for cleanliness, and check the optical path for any disturbances. The field service representative performed precision studies after the recommended service actions had been performed.
Patient Sequence No: 1, Text Type: N, H10
[52788107]
A specific root cause could not be determined based on the provided information. The issue was likely related to maintenance of the instrument as controls were fluctuating as well. The issue did not recur after service actions were performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00787 |
| MDR Report Key | 5738052 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-06-21 |
| Date of Report | 2016-08-16 |
| Date of Event | 2016-06-07 |
| Date Mfgr Received | 2016-06-09 |
| Date Added to Maude | 2016-06-21 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | CEDIA(R) CARBAMAZEPINE ASSAY |
| Generic Name | ENZYME IMMUNOASSAY, CARBAMAZEPINE |
| Product Code | KLT |
| Date Received | 2016-06-21 |
| Model Number | NA |
| Catalog Number | 04874625190 |
| Lot Number | 62007100 |
| ID Number | NA |
| Device Expiration Date | 2017-05-31 |
| 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 462500457 US 462500457 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-21 |