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 2018-06-22 for BCS XP 10459330 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[112566045]
Siemens healthcare diagnostics is investigating the cause of the multiple discordant patient sample results that were obtained on the bcs xp instrument (serial number (b)(4)).
Patient Sequence No: 1, Text Type: N, H10
[112566046]
Multiple discordant patient sample results were obtained on the bcs xp instrument (serial number (b)(4)). Customer stated that 5-10 erroneous patient sample results were reported to the physician(s), however, the customer did not provide any data or test results. Some of the test results were questioned by the physician(s) and some corrected results were reported. In addition, the customer also stated that the reagent probe was not dispensing liquid and there was a clicking noise coming from underneath the reagent probe. There are no reports of patient intervention or adverse health consequences due to the discordant patient sample results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2018-00053 |
| MDR Report Key | 7628837 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-22 |
| Date of Report | 2018-07-03 |
| Date of Event | 2018-05-30 |
| Date Mfgr Received | 2018-06-28 |
| Date Added to Maude | 2018-06-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| 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 | LORIANN RUSSO |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242287 |
| Manufacturer G1 | BIT ANALYTICAL INSTRUMENTS GMBH |
| Manufacturer Street | AM KRONBERGER HANG 3 |
| Manufacturer City | SCHWALBACH, 65824 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65824 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BCS XP |
| Generic Name | BCS XP |
| Product Code | GKP |
| Date Received | 2018-06-22 |
| Catalog Number | 10459330 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL VON BEHRING STRASSE 76 MARBURG, 35041 GM 35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-22 |