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 2016-05-23 for DIMENSION RXL MAX WITH HM manufactured by Siemens Healthcare Diagnostics Inc.
[45752583]
A siemens customer service engineer (cse) specialist was dispatched to the customer site. After evaluating the instrument, the cse tested and aligned the sample arm and the integrated multi-sensor technology arm. The cse replaced and aligned the reagent 1 probe, reagent 2 probe, sample 1 probe and heterogeneous module probe. The cse adjusted the cuvette film and primed all the probes. The cse checked all the probes and ran quality controls, which were acceptable. A siemens headquarters support center (hsc) specialist reviewed the instrument data and discovered that the data showed a high chrome value for the discordant patient sample which is consistent with a sample integrity issue. The cause of the discordant, false negative result 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
[45752584]
On (b)(6) 2016, a discordant, false negative human chorionic gonadotropin (hcg) result was obtained on one patient sample on a dimension rxl max w/hm instrument. The patient was tested for hcg two days prior and the result was positive. The discordant, false negative result was reported to the physician(s). A new sample was obtained from the patient and was tested on (b)(6) 2016 on the same instrument, resulting positive and matching the clinical picture of the patient. The corrected positive result obtained on (b)(6) 2016 was reported to the physician(s). There are no known reports of patient intervention or adverse health consequences due to the discordant, false negative hcg result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1226181-2016-00295 |
| MDR Report Key | 5673700 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-23 |
| Date of Report | 2016-05-23 |
| Date of Event | 2016-04-20 |
| Date Mfgr Received | 2016-05-03 |
| Device Manufacturer Date | 2005-11-04 |
| Date Added to Maude | 2016-05-23 |
| 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 AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242687 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 101 SILVERMINE ROAD |
| Manufacturer City | BROOKFIELD CT 06804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION RXL MAX WITH HM |
| Generic Name | CLINICAL CHEMISTRY ANALYZER |
| Product Code | NAL |
| Date Received | 2016-05-23 |
| Model Number | DIMENSION RXL MAX WITH HM |
| 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 | 101 SILVERMINE ROAD BROOKFIELD CT 06804 US 06804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-23 |