MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-03-07 for MPA 05005256002 manufactured by Roche Diagnostics.
[102124362]
Unique identifier: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[102124363]
The customer complained of questionable results for several patient samples tested for elecsys testosterone ii assay (testo) on a roche diagnostics elecsys e170 modular analytics immunoassay analyzer that had the initial samples processed by a modular pre-analytical system (mpa). The customer stated that they had to repeat several samples of which some did not match. The customer provided the testosterone data for only 1 patient. This medwatch will cover the mpa. Refer to medwatch with patient identifier (b)(6) for information on the e170 module. The patient's initial testo result of 77 ng/dl with a repeat result of 120 ng/dl. The initial result was from an aliquot processed through the mpa while the repeat result was from the primary tube being loaded onto the analyzer. The repeat result was deemed to be correct. The erroneous results were released outside of the laboratory. There were no adverse events. The testosterone reagent lot was 23299404 with an expiration date of 31-aug-2018. The field engineering specialist was unable to find a root cause. He checked the mpa operation and verified that their were no abnormal splashes and/or carry over. The customer's leak check passed on the day of event. The field engineering specialist verified the systems operations and the instrument is considered in good working order.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2018-00695 |
| MDR Report Key | 7320691 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-07 |
| Date of Report | 2018-05-29 |
| Date of Event | 2018-02-17 |
| Date Mfgr Received | 2018-02-16 |
| Date Added to Maude | 2018-03-07 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | MPA |
| Generic Name | AUTOMATED PREANALYTICAL SYSTEM |
| Product Code | CDZ |
| Date Received | 2018-03-07 |
| Model Number | MPA |
| Catalog Number | 05005256002 |
| 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 | MPA |
| Generic Name | AUTOMATED PREANALYTICAL SYSTEM |
| Product Code | JQP |
| Date Received | 2018-03-07 |
| Model Number | MPA |
| Catalog Number | 05005256002 |
| 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 | 2018-03-07 |