MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2017-03-29 for IMMULITE manufactured by Siemens Healthcare Diagnostics Inc..
[71277222]
A siemens field applications specialist (fas) was dispatched to the customer site. The fas ran multiple replicates of adjustors, quality control materials and two patient samples and did not observe a precision issue. The fas advised the customer about sample collection and handling precautions. The customer has not encountered variable results on any other patient sample(s) on the immulite hcg assay. The customer is not having issues with any other results from this immulite instrument. The cause of the discordant hcg results on this patient 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
[71277223]
The customer obtained discordant hcg results on multiple draws from a patient on an immulite instrument using reagent lot 440. The initial result was reported to physician(s), who questioned it. Repeat testing was performed on the same sample as well as on subsequent blood draws from this patient on the immulite hcg assay. Some of these samples were also tested for hcg on an alternate platform. It is unknown if the repeat results have been provided to physician(s). It is unknown if the discordant hcg results have impacted diagnosis or treatment for this patient. It is unknown if there was a delay in administering treatment or medical intervention to the patient due to the discordant hcg results.
Patient Sequence No: 1, Text Type: D, B5
[73950178]
The initial mdr 2247117-2017-00042 was filed on march 29, 2017. Additional information (04/11/2017): a siemens headquarters support center (hsc) specialist reviewed the information provided by the customer and stated that there was no imprecision noted on other samples, adjustors or quality control materials. The cause of the event could not be determined, but sample integrity may have been an issue. Based on the available information, immulite hcg lot 440 is performing as intended. The cause of the discordant, hcg results on this patient is unknown. No further evaluation of the device is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2247117-2017-00042 |
| MDR Report Key | 6443387 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2017-03-29 |
| Date of Report | 2017-04-18 |
| Date of Event | 2017-03-06 |
| Date Mfgr Received | 2017-04-11 |
| Date Added to Maude | 2017-03-29 |
| 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 | DEVYANI CHAUDHURI |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242637 |
| 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 |
| Generic Name | IMMULITE |
| Product Code | JJQ |
| Date Received | 2017-03-29 |
| Model Number | IMMULITE |
| 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 | 2017-03-29 |