MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,foreign,health profe report with the FDA on 2015-07-30 for FREE PSA manufactured by Roche Diagnostics.
[6035331]
The customer received questionable total (free + complexed) psa - prostate-specific antigen (tpsa) and free psa results for multiple samples from one patient. The samples were tested on cobas e601 serial number (b)(4). Refer to the medwatch with patient identifier (b)(6) for the total psa assay. On 05/27/2015, the tpsa was 0. 32 ng/ml and free psa was 0. 42 ng/ml. On (b)(6) 2015, the tpsa was 0. 235 ng/ml and free psa was 0. 513 ng/ml. The sample was repeated and the tpsa was 0. 232 ng/ml and free psa was 0. 516 ng/ml. The sample was tested on cobas e601 serial number (b)(4) and the tpsa was 0. 219 ng/ml and free psa was 0. 354 ng/ml. A second sample drawn (b)(6) 2015 was tested and the tpsa was 0. 227 ng/ml and free psa was 0. 508 ng/ml. The erroneous results were reported outside the laboratory. The patient was not adversely affected. The free psa reagent expiration date was given as "2016-05".
Patient Sequence No: 1, Text Type: D, B5
[13967573]
This event occurred in (b)(6). Unique identifier (udi)#: asku.
Patient Sequence No: 1, Text Type: N, H10
[26785702]
Sample from the patient was submitted for investigation and the customer's results were confirmed on a cobas (b)(4). No anti-idiotype or (b)(4) interferences were found in the sample. An unknown interfering substance was identified by adding a psa specific antibody with different specificity to the tpsa reagent. This type of interference is described in product labeling. Further investigation was not possible as no sample material remained.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2015-03887 |
| MDR Report Key | 4953349 |
| Report Source | 01,05,06,FOREIGN,HEALTH PROFE |
| Date Received | 2015-07-30 |
| Date of Report | 2015-09-02 |
| Date of Event | 2015-05-27 |
| Date Mfgr Received | 2015-07-14 |
| Date Added to Maude | 2015-07-30 |
| 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 | FREE PSA |
| Generic Name | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA |
| Product Code | MTG |
| Date Received | 2015-07-30 |
| Model Number | NA |
| Catalog Number | ASKU |
| Lot Number | 183535 |
| 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 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-30 |