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 2018-04-16 for ELECSYS 2010 ANALYZER 2010 RACK manufactured by Roche Diagnostics.
[106147109]
This event occurred in (b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[106147110]
The customer complained of discrepant results for 2 samples from 1 patient tested for elecsys total psa immunoassay (total psa) on a elecsys 2010 analyzer. The initial total psa result from the primary tube was 13. 96 ng/ml. On (b)(6) 2018 the sample was repeated from an aliquot in a standard cup with a result of 3. 31 ng/ml. On (b)(6) 2018 the sample was repeated from an aliquot in a standard cup with a result of 3. 70 ng/ml. The result of 3. 70 ng/ml was reported outside of the laboratory where it was questioned by the physician. On (b)(6) 2018 a new sample was obtained and the initial result from the primary tube was 3. 00 ng/ml. The sample from the primary tube was repeated with a result of 16. 83 ng/ml. The sample was repeated from an aliquot in a standard cup with a result of 16. 14 ng/ml. The sample was sent to an external laboratory using an unspecified clia method and the result was 15. 26 ng/ml. The result of 15. 26 ng/ml was reported outside of the laboratory. There was no allegation that an adverse event occurred. The total psa reagent lot number was 247045. The expiration date was not provided. The customer doesn't run qc every day and when qc was run, some results were outside of the acceptable range. According to the customer, no fibrin or bubbles were observed in either sample. Service was not performed on the instrument because the instrument has since been uninstalled and replaced with a cobas e 411 immunoassay analyzer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-01172 |
| MDR Report Key | 7432497 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-04-16 |
| Date of Report | 2018-05-01 |
| Date of Event | 2018-03-09 |
| Date Mfgr Received | 2018-03-27 |
| Date Added to Maude | 2018-04-16 |
| 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 |
| 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 | HITACHI HIGH TECH CORP. |
| Manufacturer Street | 882 ICHIGE HITACHINAKA NA |
| Manufacturer City | IBARAKI 312-8504 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 312-8504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECSYS 2010 ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | LTJ |
| Date Received | 2018-04-16 |
| Model Number | 2010 RACK |
| Catalog Number | ASKU |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 2010 ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2018-04-16 |
| Model Number | 2010 RACK |
| Catalog Number | ASKU |
| Lot Number | NA |
| 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 | 2018-04-16 |