MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-01-02 for IMMULITE 2000 30002 manufactured by Siemens Healtchcare Diagnostics Inc.
[5287026]
A discordant, falsely low progesterone result was obtained on one patient sample on an immulite 2000 instrument. The discordant result was reported to the physician(s). The sample was repeated for validation on the same instrument, resulting higher. The sample was then repeated again on the same instrument, resulting similarly to the previous repeat result. It is unknown if the corrected result was reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low progesterone result.
Patient Sequence No: 1, Text Type: D, B5
[12612386]
The customer contacted the siemens customer care center (ccc). The customer stated to ccc that the sample appeared slightly hemolyzed and that quality controls were within range at the time of event. It was discovered that the customer was centrifuging patient samples outside of the tube manufacturer specifications. A siemens customer service engineer (cse) was dispatched to the customer site. After evaluation of the instrument and instrument data, the cse replaced the reagent dual resolution diluter due to a cracked lower piston and the dilution well due to a noisy bearing. The cse decontaminated the fluidic and substrate systems. Quality controls and a water test were run, all of which passed. The cause of the discordant, falsely low progesterone result is unknown. The cause of the samples being centrifuged outside of tube vendor specifications is failure to follow instructions. The instrument is performing according to specifications. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2015-00001 |
| MDR Report Key | 4377975 |
| Report Source | 05,06 |
| Date Received | 2015-01-02 |
| Date of Report | 2014-12-09 |
| Date of Event | 2014-12-08 |
| Date Mfgr Received | 2014-12-09 |
| Date Added to Maude | 2015-01-20 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CASSANDRA KOCSIS |
| Manufacturer Street | 511 BENEDICT AVENUE |
| 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 | JLX |
| Date Received | 2015-01-02 |
| Model Number | IMMULITE 2000 |
| Catalog Number | 30002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTCHCARE DIAGNOSTICS INC |
| Manufacturer Address | 62 FLANDERS BARTLEY RD FLANDERS NJ 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-02 |