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 2017-08-09 for ELECSYS FREE PSA IMMUNOASSAY manufactured by Roche Diagnostics.
[83750538]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[83750539]
The customer stated that they received questionable results for one patient sample tested for multiple assays on the cobas 6000 e 601 module (e601). Of the questioned results, there were erroneous results for the following assays: elecsys ft3 iii (ft3), the elecsys ft4 ii assay (ft4), the elecsys tsh assay (tsh), the elecsys myoglobin immunoassay (myo), elecsys ferritin (ferr), the elecsys free psa immunoassay (fpsa), and the elecsys cortisol test system (cort). It was asked, but it is not known if the erroneous results were reported outside of the laboratory. Roche markets the following myo assays: elecsys myoglobin immunoassay and elecsys myoglobin stat immunoassay. It was asked, but it is not known which myo assay was used for sample testing. Roche markets the following cort assays: elecsys cortisol test system and elecsys cortisol ii. It was asked, but it is not known which cort assay was used for sample testing. The sample was collected on (b)(6) 2017 and tested on the e601 and abbott analyzers on 07/06/2017 and 07/11/2017. The customer believes that the sample may contain an interferent which interferes with the roche assays. An additional myo value of 21. 30 ug/ml was provided. It could not be clarified if this was an additional myo value from the patient sample, or if it was provided in error. A clarification has been requested. The cort results were measured after one freeze/thaw cycle of the sample. This medwatch will apply to the fpsa assay. Refer to the following manufacturer report reference numbers for information related to the ft3, ft4, and tsh assays: (b)(4). Refer to the medwatches with the following a1. Patient identifiers for information related to the myo, ferr, and cort assays: pt-(b)(6) = fpsa, pt-(b)(6) = ferr, pt-(b)(6) = cort. No adverse events were alleged to have occurred with the patient. The serial number of the e601 analyzer used at the customer site was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01654 |
| MDR Report Key | 6776733 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-09 |
| Date of Report | 2017-09-05 |
| Date of Event | 2017-07-06 |
| Date Mfgr Received | 2017-07-13 |
| Date Added to Maude | 2017-08-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 FREE PSA IMMUNOASSAY |
| Generic Name | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA |
| Product Code | MTG |
| Date Received | 2017-08-09 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 462500457 US 462500457 |
| Brand Name | ELECSYS FREE PSA IMMUNOASSAY |
| Generic Name | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA |
| Product Code | MTG |
| Date Received | 2017-08-09 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | ASKU |
| 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 | 2017-08-09 |