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 2016-01-25 for IMMULITE 2000 manufactured by Siemens Healthcare Diagnostics Inc..
[36822352]
A siemens customer service engineer (cse) was dispatched to the customer site. After evaluating the instrument and instrument data, the cse replaced the wash spinner and wash sump pump due to visible rust from the wash spinner. The cse also replaced the luminometer chain and detent gasket and aligned and tensioned the luminometer chain. A siemens regional support center (rsc) specialist evaluated the instrument data to determine if there were errors in the instrument level-sensing, which could cause inadequate sample volume to be aspirated for testing. The level sensing for patient id (b)(4) was inconclusive. The other level-sensing data was reviewed did not show any issues. A siemens technical applications specialist generated a precision study on hcg with the customer's quality controls. Precision for the assay and instrument resulted as expected. Quality controls on the day of event were within expected range. A siemens headquarters support center specialist evaluated the service report and instrument data and could not determine a cause for the discordant, false negative hcg result. The instrument data did not show a systemic issue. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
[36822353]
A discordant, false negative human chorionic gonadotropin (hcg) result was obtained on one patient sample tested on an immulite 2000 instrument on (b)(6), 2015. The discordant result was reported to the physician(s) and the patient was instructed to stop taking medication. On (b)(6), 2015, the patient went to the emergency room (er) due to cramps. A new sample was drawn in the er and run on a different instrument, resulting with a positive hcg result. The patient miscarried and the fertility laboratory was notified. The original sample from the patient was repeated on the immulite 2000 instrument and resulted positive. A corrected report was issued to the physician(s).
Patient Sequence No: 1, Text Type: D, B5
[39252808]
The initial mdr 2247117-2016-00006 was filed on january 25, 2016. Additional information (02/03/2016): the patient was an in vitro fertilization patient. Additional information (02/15/2016): siemens attempted to further investigate the event. The customer would not provide medication information due to their patient privacy practices.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2016-00006 |
| MDR Report Key | 5389959 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-01-25 |
| Date of Report | 2015-12-29 |
| Date of Event | 2015-12-14 |
| Date Mfgr Received | 2016-02-03 |
| Date Added to Maude | 2016-01-25 |
| 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. CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY RD |
| 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 | DHA |
| Date Received | 2016-01-25 |
| Model Number | IMMULITE 2000 |
| 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 2000 |
| Generic Name | IMMULITE 2000 |
| Product Code | DGC |
| Date Received | 2016-01-25 |
| Model Number | IMMULITE 2000 |
| 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 INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-25 |