MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-10-16 for ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER E MODULE 03023109001 manufactured by Roche Diagnostics.
[90545051]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[90545052]
The customer stated that they received erroneous results for four patient samples tested for the elecsys cea assay (cea) on a roche diagnostics elecsys e170 modular analytics immunoassay analyzer (e170). The first sample initially resulted as 0. 2 ug/l and this value was reported outside of the laboratory to medical personnel. The sample was repeated on the same analyzer, resulting as 2. 0 ug/l on (b)(6) 2017. The second sample initially resulted as 0. 2 ug/l (b)(6) 2017. The sample was repeated on the same analyzer, resulting as 1159. 0 ug/l on (b)(6) 2017. No erroneous results were reported outside of the laboratory for this sample. The third sample initially resulted as 0. 2 ug/l on (b)(6) 2017 and this value was reported outside of the laboratory. The sample was repeated on a different e170 analyzer, resulting as 4. 4 ug/l on (b)(6) 2017. The fourth sample initially resulted as 0. 2 ug/l on (b)(6) 2017 and this value was reported outside of the laboratory. The sample was repeated on a different e170 analyzer, resulting as 3. 7 ug/l on (b)(6) 2017. No adverse events were alleged to have occurred with the patients. The cea reagent lot number and expiration date were asked for, but not provided. The patient samples were received in aliquot tubes from another laboratory. The type of aliquot tube used is suspected to be a possible cause of the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-02334 |
| MDR Report Key | 6951991 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-10-16 |
| Date of Report | 2017-11-21 |
| Date of Event | 2017-08-23 |
| Date Mfgr Received | 2017-09-27 |
| Date Added to Maude | 2017-10-16 |
| 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 | 0 |
| 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 | ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | DHX |
| Date Received | 2017-10-16 |
| Model Number | E MODULE |
| Catalog Number | 03023109001 |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-16 |