MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-10 for IMMULITE 2000 0300002 manufactured by Siemens Healthcare Diagnostics Inc..
[17604149]
A discordant low (false negative) cmv igg (cytomegalovirus igg) result was obtained with one (1) patient sample on an immulite 2000 analyzer. The discordant result was released to the physician. The physician questioned the negative result due to the patient's history. A new sample was drawn and tested, and corrected results were reported. Patient care was not altered or prescribed due to the discordant cmv igg result. There was no known report of adverse health consequences due to the discordant cmv igg result.
Patient Sequence No: 1, Text Type: D, B5
[17820606]
A siemens healthcare diagnostics technical service engineer (tse) analyzed the instrument data. Analysis of the instrument data showed that the cmv igg lot 268 kit adjustment performed on (b)(6) 2011 was not validated by the operator. The customer confirmed that the technician who performed the (b)(6) 2011 kit adjustment made an error when running the cvgpos control. The customer also noted that the technician who performed the adjustment was inexperienced, and did not notice that the cvgpos control values were out of range (low). The technician did not realize the adjustment was not valid and ran the patient's sample, in spite of the control results for that day reflecting that the adjustment was problematic. A repeat kit adjustment for cmv igg lot 268 was successfully performed by another technician on (b)(6) 2011. The instrument is performing according to specifications. No further evaluation of the instrument is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2011-00070 |
| MDR Report Key | 2332356 |
| Report Source | 05,06 |
| Date Received | 2011-11-10 |
| Date of Report | 2011-10-18 |
| Date of Event | 2011-09-17 |
| Date Mfgr Received | 2011-10-18 |
| Date Added to Maude | 2012-05-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LINDA BARLETTA |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242299 |
| 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 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IMMULITE 2000 |
| Generic Name | IMMUNO-ASSAY |
| Product Code | OMI |
| Date Received | 2011-11-10 |
| Model Number | IMMULITE 2000 |
| Catalog Number | 0300002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS INC. |
| Manufacturer Address | FLANDERS NJ 07835 US 07835 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-10 |