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 2016-08-08 for PROLACTIN G2 03203093190 manufactured by Roche Diagnostics.
[51373473]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[51373474]
The customer stated that they received an erroneous result for one patient sample tested for prolactin on a roche analyzer. The sample resulted as 28. 58 ng/ml when tested on the roche analyzer and this value was reported outside of the laboratory. The sample was repeated on a siemens instrument, resulting as 18. 8 ng/ml. The 18. 8 ng/ml was the clinically expected result for this patient. The patient was not adversely affected. The roche analyzer model was asked for, but not provided. The serial number of the roche analyzer was (b)(4). The customer tested three additional patient samples on roche analyzers, including an e601 analyzer. The data from these samples were not used for diagnostic purposes. These samples were repeated on (b)(4) centaur and (b)(4) analyzers. The results from the roche instrument were higher when compared to results from the other 2 competitor methods. A specific root cause could not be determined based on the provided information. Additional information required for the investigation was requested, but not provided. From the sample results provided, the contribution of macro-prolactin within these samples is possible. The presence of macro-prolactin can be also concluded from the fact that the centaur results were the lowest. No issues could be seen with calibration and control results. It is assumed that the result difference is caused by sample-specific differences seen by different assays. In order to rule out the presence of macro-prolactin, it was recommended for the customer to perform a polyethylene glycol (peg) precipitation of the samples as outlined in the package insert. The customer was not able to perform the peg precipitation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2016-01129 |
| MDR Report Key | 5853368 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-08 |
| Date of Report | 2016-08-08 |
| Date of Event | 2016-07-17 |
| Date Mfgr Received | 2016-07-20 |
| Date Added to Maude | 2016-08-08 |
| 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 | PROLACTIN G2 |
| Generic Name | RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) |
| Product Code | CFT |
| Date Received | 2016-08-08 |
| Model Number | NA |
| Catalog Number | 03203093190 |
| Lot Number | 188354 |
| ID Number | NA |
| Device Expiration Date | 2017-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2016-08-08 |