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 2018-06-26 for TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA) 04641655190 manufactured by Roche Diagnostics.
[112574510]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[112574511]
The customer stated that they received questionable results for a total of 245 patient samples tested on a roche diagnostics elecsys e170 modular analytics immunoassay analyzer (e170). Of the 245 patient samples, 89 had erroneous test results. The erroneous results were reported outside of the laboratory to the doctor. The affected assays include: the elecsys afp assay (afp), the elecsys ca 19-9 immunoassay (ca 19-9), the elecsys cea assay (cea), the elecsys total psa immunoassay (psa), elecsys ft3 iii (free-t3), the elecsys ft4 ii assay (free-t4), and the elecsys tsh assay (tsh). Please refer to the medwatches with the following patient identifiers for information related to each affected assay: (b)(6) = tsh (b)(6) = free-t3 (b)(6) = free-t4 (b)(6) = afp (b)(6) = ca 19-9 (b)(6) = cea (b)(6) = psa. Please refer to the attachment for all patient data. The samples were initially tested on the customer's e170 analyzer (named elecsys on attachment). The elecsys values highlighted in orange are erroneous. The samples were repeated using the abbott architect and wako accuraseed methods. Sample 31 was provided for investigation where it was tested for tsh, free-t3, and free-t4 on a cobas 8000 e 801 module - e801 (see bottom of attachment). No adverse events were alleged to have occurred with the patients. The serial number of the customer's e170 analyzer is (b)(4). The serial number of the e801 analyzer used for investigation was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02046 |
| MDR Report Key | 7638739 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-26 |
| Date of Report | 2018-08-23 |
| Date of Event | 2018-06-05 |
| Date Mfgr Received | 2018-06-05 |
| Date Added to Maude | 2018-06-26 |
| 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 | TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA) |
| Generic Name | TOTAL,PROSTATE SPECIFIC ANTIGEN(NONCOMPLEXED&COMPLEXED) FOR DETECTION OF PROS |
| Product Code | MTF |
| Date Received | 2018-06-26 |
| Model Number | NA |
| Catalog Number | 04641655190 |
| 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 | 2018-06-26 |