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 2018-07-17 for TOTAL PSA, TOTAL (FREE + COMPLEXED) PSA - PROSTATE-SPECIFIC ANTIGEN (TPSA) 04641655190 manufactured by Roche Diagnostics.
[114689829]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[114689830]
The customer complained of an erroneous low result for 1 patient sample tested for elecsys total psa immunoassay (total psa) on a cobas e 411 immunoassay analyzer. The initial total psa result was 0. 02 ng/ml with a data flag. The free psa result was 0. 170 ng/ml. These results were reported outside of the laboratory where the doctor requested repeat testing. The customer stated the last time calibration was performed was on (b)(6) 2018 and the customer is only running one level of qc. The customer recalibrated the total psa reagent and repeated the test. On (b)(6) 2018 the sample was repeated and the total psa result was 0. 347 ng/ml and the free psa result was 0. 191 ng/ml. There was no allegation that an adverse event occurred. The total psa reagent lot number was 29152806 with an expiration date of 31-mar-2019. The customer's calibration signals from 11-jun-2018 were higher than expected for cal1 and lower than expected for cal2. After the customer re-calibrated, the signals for cal1 were ok but the cal 2 signals were still lower than expected. Qc level 1 from (b)(6) 2018 and (b)(6) 2018 were within the specified ranges. Qc level 2 from (b)(6) 2018 and (b)(6) 2018 were within the specified ranges. Product labeling states that qc should be run at least every 24 hours when the test is in use, once per reagent kit and following each calibration. No issues were identified during a review of the customer's alarm trace data. No issues were noted with the customer's pre-analytical data. The field service engineer (fse) visited the customer site and advised the customer about the importance of running both levels of qc and performing calibration at the appropriate intervals. Based on the data provided, an assay related issue is not suspected. A general product problem can be excluded. The investigation was unable to determine a definitive root cause.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-02369 |
| MDR Report Key | 7694525 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-17 |
| Date of Report | 2018-07-17 |
| Date of Event | 2018-07-02 |
| Date Mfgr Received | 2018-07-03 |
| Date Added to Maude | 2018-07-17 |
| 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 | 2018-07-17 |
| Model Number | NA |
| Catalog Number | 04641655190 |
| Lot Number | 29152806 |
| Device Expiration Date | 2019-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2018-07-17 |