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 2017-02-24 for IMMULITE manufactured by Siemens Healthcare Diagnostics Inc..
[68381599]
The customer contacted the siemens customer care center (ccc). The customer stated that quality controls (qc) were acceptable during the time of the event. Upon the ccc specialist's recommendations, the customer ran precision testing and determined additional discordant results on three patient samples. A siemens customer service engineer was dispatched to the customer site. The cse evaluated the instrument and performed 45 unit test run, which was acceptable. The cause of the discordant, falsely low progesterone result on four patient samples is unknown. The device is performing within manufacturing specification. No further evaluation of device is required.
Patient Sequence No: 1, Text Type: N, H10
[68381600]
The customer obtained discordant, falsely low progesterone results on four patient samples on an immulite instrument. The initial results were not reported to the physician(s). The customer repeated the samples on the same instrument, resulting higher. The repeat results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequence due to the discordant, falsely low progesterone results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247117-2017-00018 |
| MDR Report Key | 6357148 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-02-24 |
| Date of Report | 2017-02-24 |
| Date of Event | 2017-01-31 |
| Date Mfgr Received | 2017-02-01 |
| Date Added to Maude | 2017-02-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MARIE SYLVESTRE |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243172 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY ROAD |
| Manufacturer City | FLANDERS NJ 07836 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07836 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE |
| Generic Name | IMMULITE |
| Product Code | JLS |
| Date Received | 2017-02-24 |
| Model Number | IMMULITE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY RD. FLANDERS NJ 07836 US 07836 |
| Brand Name | IMMULITE |
| Generic Name | IMMULITE |
| Product Code | JJE |
| Date Received | 2017-02-24 |
| Model Number | IMMULITE |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY RD. FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-24 |