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 2018-01-03 for IMMULITE 2000 manufactured by Siemens Healthcare Diagnostics Inc..
[96497140]
The customer contacted the siemens customer care center (ccc). The ccc specialist reviewed adjustment guidelines with the customer. The customer readjusted the kit lot with a fresh set of adjustors and adjustment slope returned to historical performance and quality control (qc) resulted in range. The cause for the customer to report patient results while qc was out of range is due to user error. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[96497141]
Discordant thyroid stimulating hormone (tsh) results were obtained on multiple patient samples on an immulite 2000 instrument when quality control (qc) level 1 was out of range low. And this is documented in the data logs. These discordant results were reported to the physician(s), who did not question the results. The same samples were repeated on an alternate immulite 2000 instrument. The corrected results were reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant tsh results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247117-2018-00001 |
| MDR Report Key | 7162122 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-03 |
| Date of Report | 2018-01-03 |
| Date of Event | 2017-12-07 |
| Date Mfgr Received | 2017-12-08 |
| Date Added to Maude | 2018-01-03 |
| 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 | MS. CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY RD REGISTRATION #: 2247117 |
| 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 2000 |
| Generic Name | IMMULITE 2000 |
| Product Code | JJQ |
| Date Received | 2018-01-03 |
| Model Number | IMMULITE 2000 |
| 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 | 2018-01-03 |