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 2016-02-09 for IMMULITE 2000 XPI 030001-3 manufactured by Siemens Healthcare Diagnostics Inc..
[37741609]
The cause of the falsely low result on the immulite 2000 xpi is unknown. Siemens healthcare is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[37741610]
The customer has obtained a falsely low result on a patient sample for the estradiol assay on an immulite 2000 xpi. The initial result was not reported to the physician(s) as it did not fit the clinical picture of the patient. The patient was redrawn and the sample was tested neat, and at a 1:5 dilution and the values were within expectations. The customer then repeated the original sample that gave the falsely low result and the result obtained upon repeat was acceptable to the customer. It is unknown if the repeat results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the falsely low result obtained on the immulite 2000 xpi.
Patient Sequence No: 1, Text Type: D, B5
[40405220]
Patient Sequence No: 1, Text Type: N, H10
[40409704]
Initial mdr 2247117-2016-00007 was filed on 2/9/2016. Correction: pid# of initial mdr for the initial low result ((b)(6) 2016) was incorrectly listed as (b)(4). The correct pid# is (b)(4). The pid# for the redraw on (b)(6) 2016 is (b)(4). Additional information (02/22/2016): please note information on new patient sample. Siemens healthcare has contacted the customer site and requested that the samples be shipped to siemens for in-house testing. The instrument files have also been received by siemens headquarters support center (hsc) for review. On 2/25/2016 siemens hsc reviewed the instrument files provided by the customer for the initial discordant result reported in mdr 2247117-2016-0007. There was nothing observed in the instrument files that indicated a malfunction in the instrument while the sample was running. The cause of the initial discordant is unknown. Siemens healthcare is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[40409705]
A second falsely low result was obtained on a patient sample for the estradiol assay on an immulite 2000 xpi. The patient sample was run neat and at a 1:5 dilution. The neat result was lower than the result obtained on the 1:5 dilution. The sample was repeated again neat and at a 1:5 dilution, and the results obtained were acceptable to the customer. It is unknown if the initial and repeat results were reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the falsely low result obtained on the immulite 2000 xpi.
Patient Sequence No: 1, Text Type: D, B5
[41353924]
Initial mdr 2247117-2016-00007 was filed on 2/9/2016. Follow up mdr 2247117-2016-00007_s1 was filed on 3/14/2016. Follow up mdr 2247117-2016-00007_s2 was filed on 3/16/2016. Additional information (3/16/2016): siemens headquarters support center (hsc) reviewed the instrument files provided by the customer for the additional two discordant results for the estradiol assay provided in mdr follow up 2247117-2016-00007_s1. Quality control samples and adjustments for the assay were within specifications when the samples were run. There were no errors and nothing observed in the instrument files that indicated a malfunction with the instrument while the samples were being processed. Samples were received by siemens from the customer site but were incorrectly shipped at room temperature instead of frozen as per the instructions for use (ifu). As the samples could be compromised in-house testing cannot be carried out, and further investigation has been cancelled. The cause of the additional two discordants is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2016-00007 |
| MDR Report Key | 5418573 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-02-09 |
| Date of Report | 2016-01-15 |
| Date of Event | 2016-01-13 |
| Date Mfgr Received | 2016-03-16 |
| Date Added to Maude | 2016-02-09 |
| 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, INC. |
| Manufacturer Street | 62 FLANDERS BARTLEY ROAD P.O. BOX 6101 |
| Manufacturer City | FLANDERS NJ 078366101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 078366101 |
| 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 | CHP |
| Date Received | 2016-02-09 |
| Model Number | IMMULITE 2000 XPI |
| Catalog Number | 030001-3 |
| Device Availability | * |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | 62 FLANDERS BARTLEY ROAD FLANDERS NJ 07836 US 07836 |
| Brand Name | IMMULITE 2000 XPI |
| Generic Name | IMMULITE 2000 XPI |
| Product Code | JJQ |
| Date Received | 2016-02-09 |
| Model Number | IMMULITE 2000 XPI |
| Catalog Number | 030001-3 |
| Device Availability | * |
| 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 ROAD FLANDERS NY 07836 US 07836 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-02-09 |