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 2019-02-05 for DIMENSION? DF34 SMN 10444903 manufactured by Siemens Healthcare Diagnostics Inc.
[137004325]
Mdrs 2517506-2019-00048, 2517506-2019-00049, 2517506-2019-00050, 2517506-2019-00051 and 2517506-2019-00053 were filed for the same event. Siemens healthcare diagnostics headquarters support center (hsc) concluded their investigation of the discordant, falsely elevated c-reactive protein (rcrp) result. The customer tested a sample with the siemens rcrp reagent after treatment of the patient sample with nabt (non-specific antibody blocking tubes) and hbt (heterophilic blocking tubes) and obtained rcrp results with 35% and 63% interference attenuation. Per the dimension exl system instructions for use for rcrp: "patient samples may contain heterophilic antibodies that could react in immunoassays to give falsely elevated or depressed results. This assay has been designed to minimize interference from heterophilic antibodies. Nevertheless, complete elimination of this interference from all patient specimens cannot be guaranteed. " the cause of the elevated result was determined to be non-specific antibody interference on this patient. No product or system non-conformance identified. The device is performing within specifications. No further evaluation is required.
Patient Sequence No: 1, Text Type: N, H10
[137004326]
A discordant, falsely elevated c-reactive protein (rcrp) result was obtained on a patient sample on the dimension exl system. The discordant result was reported to the physician who questioned the result. The patient was administered antibiotics. A new sample from the same patient was processed using two alternate methodologies and lower results were obtained. There are no reports of adverse health consequences due to the discordant, elevated rcrp result or due the patient's antibiotic treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2517506-2019-00052 |
| MDR Report Key | 8304761 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-02-05 |
| Date of Report | 2019-02-05 |
| Date of Event | 2019-01-09 |
| Date Mfgr Received | 2019-01-15 |
| Device Manufacturer Date | 2018-08-01 |
| Date Added to Maude | 2019-02-05 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JAMES MORGERA |
| Manufacturer Street | 500 GBC DRIVE P.O. BOS 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal | 197146101 |
| Manufacturer Phone | 3026318356 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS INC |
| Manufacturer Street | 500 GBC DRIVE P.O. BOS 6101 |
| Manufacturer City | NEWARK DE 197146101 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 197146101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIMENSION? |
| Generic Name | DIMENSION? EXL RCRP C-REACTIVE PROTEIN EXTENDED RANGE FLEX? REAGENT CARTRIDGE |
| Product Code | DCN |
| Date Received | 2019-02-05 |
| Catalog Number | DF34 SMN 10444903 |
| Lot Number | FB9214 |
| Device Expiration Date | 2019-08-02 |
| 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 | 500 GBC DRIVE P.O. BOS 6101 NEWARK DE 197146101 US 197146101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-05 |