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 2016-12-22 for ELECSYS PROLACTIN ASSAY 03203093190 manufactured by Roche Diagnostics.
[63206398]
This event occurred in (b)(6). (b)(4). Medwatch field expiration date was provided as february 2017. (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[63206399]
The customer stated that they received erroneous results for one patient sample tested for the elecsys prolactin assay (prl) on a cobas e 411 immunoassay analyzer (e411). The patient sample initially resulted as 78. 47 ng/ml and this value was reported outside of the laboratory. The sample was also repeated on (b)(6) 2016, resulting as 74. 29 ng/ml. A new sample was collected from the patient and tested on a centaur analyzer on (b)(6) 2016, resulting as 18. 80 ng/ml. A result value of 12. 7 ng/ml from (b)(6) 2016 was also provided, but it is not clear if this result was from the initial sample, the new sample, from a different patient sample, or if it had been documented in error. A clarification has been requested. The patient was not adversely affected. The serial number of the e411 analyzer was asked for, but not provided.
Patient Sequence No: 1, Text Type: D, B5
[63387735]
It has been confirmed that the value of the new sample tested on the centaur analyzer on (b)(6) 2016 was actually 12. 7 ng/ml. The value of 18. 80 ng/ml was provided in error.
Patient Sequence No: 1, Text Type: N, H10
[68569252]
A specific root cause could not be determined based on the provided information. Additional information required for the investigation was requested, but not provided. No general reagent issue is evident. Different prl levels were measured with the roche method and the centaur method, but direct comparison measurements of the two methods were not performed with either of the two samples. Based on available data, it could not be confirmed if there is really a discrepancy between the two methods. Possible differences in results may occur if the patient has macro-prolactin in their serum. The presence of macro-prolactin in the sample would yield a higher value with the roche prl method. The two samples may also not have been from the same patient, but this could not be confirmed. Clinical differences in prl levels may also occur over several days.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-02046 |
| MDR Report Key | 6198299 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-22 |
| Date of Report | 2017-02-24 |
| Date of Event | 2016-11-12 |
| Date Mfgr Received | 2016-11-30 |
| Date Added to Maude | 2016-12-22 |
| 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 | ELECSYS PROLACTIN ASSAY |
| Generic Name | RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) |
| Product Code | CFT |
| Date Received | 2016-12-22 |
| Model Number | NA |
| Catalog Number | 03203093190 |
| Lot Number | 188354 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2016-12-22 |