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 2017-08-21 for ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER E MODULE manufactured by Roche Diagnostics.
[85581075]
(b)(6). (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[85581076]
The customer stated that they received an erroneous result for one patient sample tested for elecsys c-peptide (cpep) on a roche diagnostics elecsys e170 modular analytics immunoassay analyzer (e170). The sample initially resulted as < 0. 10 ng/ml and this value was reported outside of the laboratory to the patient. The sample was repeated after a complaint was received about the initial result. The sample was kept frozen and thawed before repeating. The sample was repeated on (b)(6) 2017, resulting as 2. 62 ng/ml. The repeat value was considered to be correct and agreed with the patient's history. No adverse events were alleged to have occurred with the patient. The reagent lot number was 173976. The reagent expiration date was asked for, but not provided. The alarm trace showed no relevant alarms around the time the sample was pipetted. Calibration signal values were lower than expected for the last calibration performed on 07/24/2017. Controls were within range on (b)(6) 2017 and (b)(6) 2017. A specific root cause could not be determined based on the provided information. Possible root causes include foam/bubbles on the sample surface, a tilted sample tube in the rack in combination with wet inner tube walls, sample quality, or insufficient maintenance.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2017-01778 |
| MDR Report Key | 6807478 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-08-21 |
| Date of Report | 2017-08-21 |
| Date of Event | 2017-07-25 |
| Date Mfgr Received | 2017-08-02 |
| Date Added to Maude | 2017-08-21 |
| 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 | ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JKD |
| Date Received | 2017-08-21 |
| Model Number | E MODULE |
| 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 | ROCHE DIAGNOSTICS ELECSYS E170 MODULAR ANALYTICS IMMUNOASSAY ANALYZER |
| Generic Name | IMMUNOCHEMISTRY ANALYZER |
| Product Code | JJE |
| Date Received | 2017-08-21 |
| Model Number | E MODULE |
| Catalog Number | ASKU |
| Lot Number | NA |
| ID Number | NA |
| 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 | 2017-08-21 |