MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2016-01-07 for IMMULITE 2000 XPI manufactured by Siemens Healthcare Diagnostics Inc..
[35288705]
The customer contacted a siemens customer care center (ccc) specialist. The customer stated that calibrations and quality controls were acceptable at the time of the sample run. Siemens healthcare diagnostics is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[35288706]
Discordant, false non-reactive cytomegalovirus igg (cmv igg) and cytomegalovirus igm (cmv igm) results were obtained on one patient sample on an immulite 2000 xpi instrument. The discordant results were reported to the physician(s). A new sample was obtained from the patient and was tested on the same instrument, resulting reactive. The original sample was then repeated on the same instrument, also resulting reactive. The corrected results were reported to the physician(s). There are no reports of patient intervention or adverse health consequences due to the discordant, false non-reactive cmv igg and cmv igm results.
Patient Sequence No: 1, Text Type: D, B5
[37352890]
The initial mdr 2247117-2016-00002 was filed on january 07, 2016. Additional information (01/05/2016): a siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse performed a preventive maintenance and did not find any instrument malfunction. The cause of the discordant, false non-reactive cmv igg and cmv igm results on one patient sample is unknown. 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 | 2247117-2016-00002 |
| MDR Report Key | 5351373 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-01-07 |
| Date of Report | 2015-12-16 |
| Date of Event | 2015-11-30 |
| Date Mfgr Received | 2016-01-05 |
| Date Added to Maude | 2016-01-07 |
| 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 | 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 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 XPI |
| Generic Name | IMMULITE 2000 XPI |
| Product Code | LFZ |
| Date Received | 2016-01-07 |
| Model Number | IMMULITE 2000 XPI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-07 |