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 2016-04-25 for PROLACTIN G2 03203093190 manufactured by Roche Diagnostics.
[43552286]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[43552287]
The customer stated that they received erroneous results for two samples from the same patient tested for prolactin on an e411 analyzer. The erroneous results were reported outside of the laboratory to the patient. The specific date of the event was asked for, but not provided. On (b)(6) 2016, it was stated that the event occurred two months ago. The first sample was said to be repeatedly high when measured with the e411 analyzer, with one result around 1400 uiu/ml. Radioisotope testing of the sample yielded a result of 24. No units of measure were provided for the radioisotope testing result of 24, but it was stated that the most possible unit of measure is ng/ml. The second sample initially resulted as 722 uiu/ml when tested on the e411 analyzer on (b)(6) 2016. The sample was sent to another laboratory for repeat testing using a chemiluminescence immunoassay method, where it resulted as 24. 07 ng/ml. The patient was not adversely affected. The e411 analyzer serial number is (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[45771806]
A specific root cause could not be determined based on the provided information. Additional information required for the investigation was requested, but could not be provided. There was no general reagent issue evident based on the provided data.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2016-00488 |
| MDR Report Key | 5605453 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-04-25 |
| Date of Report | 2016-05-24 |
| Date of Event | 2016-02-01 |
| Date Mfgr Received | 2016-04-12 |
| Date Added to Maude | 2016-04-25 |
| 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 | 2016-04-25 |
| Model Number | NA |
| Catalog Number | 03203093190 |
| Lot Number | 188354-02 |
| 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 | 2016-04-25 |