MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-02-20 for IMMULITE 2000 30002 manufactured by Siemens Healthcare Diagnostics Inc..
[5504599]
Discordant progesterone (prg) results were obtained on fourteen patient samples on an immulite 2000 instrument. The discordant results were not reported to the physician(s). The samples were repeated on an alternate instrument, resulting higher than the initial results except for patient 88138, which resulted lower. The repeat results were not reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant progesterone results.
Patient Sequence No: 1, Text Type: D, B5
[12846379]
A siemens headquarters support center (hsc) specialist reviewed the instrument data. The cause of discordant progesterone results on fourteen patient samples is unknown. Siemens healthcare diagnostics is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[33622842]
The initial mdr 2247117-2015-00006 was filed on february 20, 2015. Additional information (04/21/2015): the falsely low progesterone results observed by the customer was investigated and it was determined that the sample collection tube type was impacting the progesterone results. The customer was using gel barrier tubes, which is an off-label use. The immulite 2000 progesterone instructions for use states that "time-dependent decreases in progesterone levels have been reported when serum samples are collected and stored in gel barrier tubes". The customer performed proficiency testing using an alternate sample collection tube type, which was acceptable. A siemens customer service engineer (cse) specialist proactively tightened the dual resolution dilutor (drd) nut and replaced the reagent and the sample probes. The instrument is performing according to the specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2015-00006 |
| MDR Report Key | 4532794 |
| Report Source | 05,06 |
| Date Received | 2015-02-20 |
| Date of Report | 2015-01-26 |
| Date of Event | 2015-11-21 |
| Date Mfgr Received | 2015-04-21 |
| Date Added to Maude | 2015-03-25 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. MICHAEL METZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242223 |
| 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 2000 |
| Generic Name | IMMULITE 2000 |
| Product Code | JLX |
| Date Received | 2015-02-20 |
| Model Number | IMMULITE 2000 |
| Catalog Number | 30002 |
| 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 | 2015-02-20 |