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 2016-01-08 for IMMULITE 2000 BR-MA manufactured by Siemens Healthcare Diagnostics Inc..
[35494229]
Siemens healthcare diagnostics is investigating the issue. The cause of the discordant, falsely elevated ca 19-9 results on one patient sample is unknown.
Patient Sequence No: 1, Text Type: N, H10
[35494230]
A discordant, falsely elevated cancer antigen (ca 19-9) result was obtained on one patient sample when diluted 1:3 on an immulite 2000 xpi instrument while using reagent lot 315. The discordant result was reported to the physician(s), who questioned it. The sample was tested in an alternate laboratory on an alternate platform, resulting lower. A new draw was obtained from the patient and was diluted with a dilution factor of 1:3 and tested on s/n: (b)(4), still resulting high. The original sample was sent to a supporting laboratory and was tested on an alternate immulite 2000 xpi instrument, also resulting high. It is unknown if the result from the alternate platform was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated ca 19-9 results.
Patient Sequence No: 1, Text Type: D, B5
[40740836]
The initial mdr 2432235-2016-00012 was filed on january 08, 2016. Additional information (02/26/2016): siemens requested the sample material from the customer for further investigation, but it was not provided. A siemens headquarters support center (hsc) specialist reviewed the patient data and indicated that they could not determine the cause of the event. The cause of the discordant, falsely elevated (b)(4) results on one patient sample is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2432235-2016-00012 |
| MDR Report Key | 5355093 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-01-08 |
| Date of Report | 2015-12-15 |
| Date of Event | 2015-10-01 |
| Date Mfgr Received | 2016-02-26 |
| Date Added to Maude | 2016-01-08 |
| 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 | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS (REG# 3002806944) |
| Manufacturer Street | GLYN RHONWY LLANBERIS, CAERNARFON |
| Manufacturer City | GWYNEDD, WALES LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 BR-MA |
| Generic Name | IMMULITE 2000 BR-MA |
| Product Code | NIG |
| Date Received | 2016-01-08 |
| Model Number | IMMULITE 2000 BR-MA |
| Lot Number | 315 |
| 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 | GLYN RHONWY LLANBERIS, CAERNARFON GWYNEDD, WALES LL554EL UK LL55 4EL |
| Brand Name | IMMULITE 2000 BR-MA |
| Generic Name | IMMULITE 2000 BR-MA |
| Product Code | MOI |
| Date Received | 2016-01-08 |
| Model Number | IMMULITE 2000 BR-MA |
| Lot Number | 315 |
| 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 | GLYN RHONWY LLANBERIS, CAERNARFON GWYNEDD, WALES LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-08 |