MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-13 for IMMULITE 2000 VITAMIN B12 manufactured by Siemens Healthcare Diagnostics Products, Limited.
[131776648]
Based on the information provided in the case report the probable cause was attributed to interference from a high titre of intrinsic factor antibody. Siemens vitamin b12 instructions for use (ifu) in the "limitations" section clearly indicates the following - blocking antibodies specific for intrinsic factor are present in more than half of all pernicious anemia patients. In order to accurately measure vitamin b12 levels in such samples it is necessary to inactivate these antibodies. While the alkaline hydrolysis has been shown to be effective in inactivating high titers of intrinsic factor blocking antibodies that may be present, the possibility that these antibodies are not fully inactivated in a are sample, especially samples with extremely high titers of these antibodies, can not be ruled out. When results obtained are in conflict with the clinical examination, patient medical history and other findings, the sample should be tested for intrinsic factor blocking antibodies. A sample pool selected for a high titer of intrinsic factor blocking antibodies could also be incorporated into the routine quality control of this assay to specifically monitor the inactivation of such antibodies during the pretreatment step. The system is performing within manufacturing specifications. No further evaluation of the device is required. Mdr 1219913-2018-00303 was also filed for the advia centaur platform.
Patient Sequence No: 1, Text Type: N, H10
[131776649]
In a case report from 2012, the advia centaur vb12 assay was reported to show normal results that were discordant with the clinical picture of the patient. The patient's clinical appearance is one of b12 deficiency. The (b)(6) woman with severe anaemia (haemoglobin 58 g/l) who had been suffering from progressively increasing palpitations, profound fatigue and exertional dyspnoea for about one month was admitted to the hospital in (b)(6) 2011. The vitamin b12 and folate deficiency were considered immediately. However, the results were in the normal range. The patient received two red cell units and was discharged from the hospital. Two weeks later the patient was admitted again with anemia based on hemoglobin levels, and when tested for vitamin b12 levels the results were in the normal range. It was decided at this point to treat the patient with a pharmacological dose of subcutaneous vitamin b12. After 2 weeks the patient's condition improved and complete clinical and haematological recovery occurred within the next month. There was no report of adverse health consequences due to the discordant vb12 results with the clinical picture.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432235-2018-00455 |
| MDR Report Key | 8162095 |
| Date Received | 2018-12-13 |
| Date of Report | 2018-12-13 |
| Date of Event | 2011-05-01 |
| Date Mfgr Received | 2018-11-14 |
| Date Added to Maude | 2018-12-13 |
| 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 | AARTI AZIZ |
| Manufacturer Street | 511 BENEDICT AVENUE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242683 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Street | UK REGISTRATION #: 3002806944 GLYN RHONWY |
| Manufacturer City | LLANBERIS, GWYNEDD LL554EL |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LL55 4EL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | IMMULITE 2000 VITAMIN B12 |
| Generic Name | IMMULITE 2000 VITAMIN B12 |
| Product Code | LIG |
| Date Received | 2018-12-13 |
| Model Number | IMMULITE 2000 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED |
| Manufacturer Address | GLYN RHONWY LLANBERIS GWYNEDD, LL554EL UK LL55 4EL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-12-13 |