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 2017-01-17 for N LATEX HCY OPAX032 SMN10445973 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[65034973]
Siemens healthcare diagnostics has observed a reduced once-opened stability and a reduced on-board stability for the affected lot 802907632 that may result in erroneously reduced or elevated homocysteine. This stability issue may lead to a higher than expected lot-to-lot variation and impaired product performance. Urgent medical device correction (umdc) pp17-005. A. Us was sent to customers in the united states on january 11, 2017 and corresponding urgent field safety notice (ufsn) br-01117_ous was sent to all outside us customers who have been shipped the impacted lot, 802907632. The umdc and ufsn titled "n latex hcy and n latex hcy (bcs? Xp) lot 802907632 does not meet once-opened and onboard stability claims" and instructs customers to discontinue use and to discard the lot.
Patient Sequence No: 1, Text Type: N, H10
[65034974]
Discordant low homocysteine (hcy) results were observed with lot 802907632 in a lot to lot comparison study on the bnii instrument when evaluating new lot 802910060. Patient results of the correlation study were not reported to the physician. There are no reports of patient intervention or adverse health consequences due to the discordant low hcy results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2017-00005 |
| MDR Report Key | 6258890 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-17 |
| Date of Report | 2017-01-17 |
| Date of Event | 2016-09-19 |
| Date Mfgr Received | 2016-12-20 |
| Device Manufacturer Date | 2016-06-03 |
| Date Added to Maude | 2017-01-17 |
| 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 | JAMES MORGERA |
| Manufacturer Street | GLASGOW BUSINESS COMMUNITY 500 GBC DRIVE PO BOX 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL VON BEHRING STRASSE 76 |
| Manufacturer City | MARBURG, D-35041 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D-35041 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 2432235-01/11/2017-001-R |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N LATEX HCY |
| Generic Name | N LATEX HCY |
| Product Code | LPS |
| Date Received | 2017-01-17 |
| Catalog Number | OPAX032 SMN10445973 |
| Lot Number | 802907632 |
| Device Expiration Date | 2017-02-13 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| 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, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-17 |