MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-05-23 for FREE PROSTATE-SPECIFIC ANTIGEN 03289788190 manufactured by Roche Diagnostics.
[12021832]
A root cause could not be determined with the information provided. There was not enough patient sample to perform an investigation.
Patient Sequence No: 1, Text Type: N, H10
[18364730]
The customer alleged they received questionable free prostate-specific antigen (fpsa) and total prostate-specific antigen (tpsa) results for one patient. The units of measure were requested but not provided. The patient's sample was tested on an analytic e-module (mod04), serial number not provided. The tpsa result was 3. 54 and the fpsa result was 4. 46. These results were reported outside the laboratory. On (b)(6) 2014, the patient was tested again on mod04. The tpsa result was 3. 58 and the fpsa result was 4. 40. On (b)(6) 2014, the patient was tested on another e-module (mod06), serial number not provided. The tpsa result was 3. 71 and the fpsa result was 4. 46. On (b)(6) 2014, the patient was tested on a third e-module (mod02), serial number not provided. The tpsa result was 3. 71 and the fpsa result was 4. 65. The customer stated this sample was measured on another instrument- abbott architect i4000 and provided the following four sets of results. On (b)(6) 2014 the tpsa result was 0. 09 and fpsa result was 2. 82. On (b)(6) 2014, the tpsa result was 0. 085 and fpsa result was 2. 91. With a 1:10 dilution, the tpsa result was 0. 07 and fpsa result was 3. 75. With a 1:2 dilution, the tpsa result was 0. 08 and fpsa result was 3. 14. Information on whether any results came from the same patient samples was requested but not provided. Information on whether any results other than the results from (b)(6) 2014 were reported outside the laboratory was requested but not provided. There were no deaths, injuries, illnesses, or deteriorations in health associated with the erroneous results. Information on whether the patient was harmed by any action taken was requested but not provided. The tpsa reagent lot number and expiration date were requested but not provided. The customer provided the serial number (b)(4). Information on which e- module that number belonged to was requested but not provided.
Patient Sequence No: 1, Text Type: D, B5
[18534507]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2014-03653 |
| MDR Report Key | 3829288 |
| Report Source | 01,05,06 |
| Date Received | 2014-05-23 |
| Date of Report | 2014-06-24 |
| Date of Event | 2014-04-26 |
| Date Mfgr Received | 2014-04-28 |
| Date Added to Maude | 2014-05-23 |
| 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 | 0 |
| 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 PROSTATE-SPECIFIC ANTIGEN |
| Generic Name | TEST,PROSTATE SPECIFIC ANTIGEN,FREE,(NONCOMPLEXED) TO DISTINGUISH PROSTATE CA |
| Product Code | MTG |
| Date Received | 2014-05-23 |
| Model Number | NA |
| Catalog Number | 03289788190 |
| Lot Number | 174624 |
| 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 | 2014-05-23 |