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 2017-09-01 for ADVIA CHEMISTRY IMMUNOGLOBULIN M_2 REAGENTS (IGM_2) 10309032 manufactured by Siemens Healthcare Diagnostics Inc..
[85613271]
A siemens regional application specialist (ras) reviewed the reaction curves and data provided by the customer and determined that the falsely low igm_2 results may have been produced by some inhibitory agent present within the sample. The manual pre-dilution of the sample reduces the effect of the interference and allows the true elevated value to be measured. The advia 2400 instrument did not generate any errors on the initial result because the reaction curve shows no abnormalities. It also shows that there was no prozone or hook effect and that the falsely low igm_2 results were not obtained directly due to an antigen excess. The ras specialist concluded that the possible causes of the discordant results could be steric hindrance by high protein concentration or non-specific binding of antibodies in igm_2 reagent to some specific agent present in the sample or some other para-protein such as presence of human anti-goat antibodies. The advia 2400 igm_2 method uses goat anti-human igm antibodies. If the patient has been exposed to goats they may have anti-goat antibodies present in their blood. If this is the cause, other igm_2 results on the advia 2400 instrument may also be falsely low. A regional support center specialist stated that the quality controls and other patient samples for igm_2 have been recovering reproducibly. Therefore, this sample appears to be an isolated incident. A siemens headquarters support center specialist reviewed the event data and concluded that this is not a method or reagent lot issue. The system is functioning as designed. Quality control was within acceptable range and only one sample was impacted. This data is consistent with interference, however, the interference could not be determined with the information available. As per advia chemistry immunoglobulin m_2 (igm_2) instructions for use state, a number of substances cause physiological changes in serum analyte concentrations. As with any chemical reaction, the customer must be alert to the possible effect on results of unknown interferences from medications or endogenous substances. The laboratory and physician must evaluate all patient results in light of the total clinical status of the patient. The system and assay is working as specified. The cause of the discordant, falsely low igm_2 results on one patient sample is unknown. The device is performing within manufacturing specifications. No further evaluation of device is required. Mdr 2432235-2017-00432 was filed for the same event.
Patient Sequence No: 1, Text Type: N, H10
[85613272]
On (b)(6) 2017, a discordant, falsely low immunoglobulin m_2 (igm_2) result was obtained on one patient sample when run neat on an advia 2400 instrument, while using reagent lot 411515. On (b)(6) 2017, the sample was analyzed using an alternate methodology, resulting high and indicative of high paraprotein band. The customer confirmed the high result by repeating the sample on the alternate methodology. This prompted the customer to repeat the sample as neat and with dilution on the advia 2400 instrument. This is when the customer determined that the neat results and a result obtained upon initial dilution on the advia 2400 instrument were discordant. The results from the electrophoresis and the results obtained on the advia 2400 instrument upon manual dilution were considered correct. The discordant result was reported to the physician(s), who questioned it. The corrected results were reported to the physician(s). There are no reports of patient intervention or adverse health consequence due to the discordant, falsely low igm_2 results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2017-00505 |
| MDR Report Key | 6838417 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-01 |
| Date of Report | 2017-09-19 |
| Date of Event | 2017-06-21 |
| Date Mfgr Received | 2017-07-06 |
| Date Added to Maude | 2017-09-01 |
| 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 | RANDOX LABORATORIES LTD. |
| Manufacturer Street | REGISTRATION # 8020890 55 DIAMOND ROAD |
| Manufacturer City | CRUMLIN, CO. ANTRIM BT294QY |
| Manufacturer Country | UK |
| Manufacturer Postal Code | BT29 4QY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADVIA CHEMISTRY IMMUNOGLOBULIN M_2 REAGENTS (IGM_2) |
| Generic Name | ADVIA CHEMISTRY IMMUNOGLOBULIN M_2 REAGENTS (IGM_2) |
| Product Code | CFN |
| Date Received | 2017-09-01 |
| Model Number | ADVIA CHEMISTRY IMMUNOGLOBULIN M_2 REAGENTS (IGM_2 |
| Catalog Number | 10309032 |
| Lot Number | 411515 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 511 BENEDICT AVE TARRYTOWN NY 10591 US 10591 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-09-01 |