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 2017-11-08 for COBAS 6000 E 601 MODULE E601 04745922001 manufactured by Roche Diagnostics.
[92609143]
This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[92609144]
The customer stated that they received an erroneous result for one patient sample tested for the elecsys total psa immunoassay (tpsa) on a cobas 6000 e 601 module (e601). The erroneous result was reported outside of the laboratory to the patient. The sample initially resulted as 9. 36 ng/ml. The result was doubted based on the patient's previous results. The sample was repeated, resulting as 0. 75 ng/ml. The sample was also repeated twice on (b)(6) 2017, each time resulting as 0. 75 ng/ml. Repeat testing for another test parameter run on the sample was ok. No adverse events were alleged to have occurred with the patient. The tpsa reagent lot number and expiration date were asked for, but not provided. The customer repeated 5 previous patient samples and all results were ok. The sample run just prior to the complained sample did not have an increased tpsa result. The customer noted that there were sample volume alarms for other tubes and these were confirmed to have low sample volume. There was no hemolysis of the complained sample and the volume was correct. Controls run before and after the complained sample were acceptable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02555 |
| MDR Report Key | 7009603 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-08 |
| Date of Report | 2017-11-20 |
| Date of Event | 2017-10-20 |
| Date Mfgr Received | 2017-10-23 |
| Date Added to Maude | 2017-11-08 |
| 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 |
| 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 | 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 | COBAS 6000 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | LTJ |
| Date Received | 2017-11-08 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| 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 | COBAS 6000 E 601 MODULE |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-11-08 |
| Model Number | E601 |
| Catalog Number | 04745922001 |
| 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 | 2017-11-08 |